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      <title>CDRH withdraws guidance for clinical evaluation of SaMD</title>
      <description>
        <![CDATA[The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation of software as a medical device, a development that seems to align with recent relaxation of digital health product regulation, but which might also be seen as the consequence of an ill-advised case of regulatory copy and paste.]]>
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      <guid>http://www.bioworld.com/articles/727821</guid>
      <pubDate>Wed, 14 Jan 2026 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727821-cdrh-withdraws-guidance-for-clinical-evaluation-of-samd</link>
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      <title>Acryl raises $28M IPO, aiming to bridge medical divide with AI</title>
      <description>
        <![CDATA[Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares priced at ₩19,500 each. Notably, Acryl won South Korea Ministry of Food and Drug Safety approval of Acryl-D01 software in December 2024, making it the country’s first AI-based digital therapeutic solution for depression screening and diagnosis. The generative AI-based medical software is cleared to analyze patient interviews and medical records and provide a probability score for clinical depression.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727084</guid>
      <pubDate>Wed, 17 Dec 2025 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727084-acryl-raises-28m-ipo-aiming-to-bridge-medical-divide-with-ai</link>
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        <media:title type="plain">IPO stock market ticker</media:title>
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      <title>MFDS clears world’s first ECG-based AI kidney disease software</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.]]>
      </description>
      <guid>http://www.bioworld.com/articles/720771</guid>
      <pubDate>Wed, 11 Jun 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720771-mfds-clears-worlds-first-ecg-based-ai-kidney-disease-software</link>
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        <media:title type="plain">Doctor with illustration of kidneys</media:title>
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    <item>
      <title>South Korea approves record number of biosimilars in 2024</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.]]>
      </description>
      <guid>http://www.bioworld.com/articles/720003</guid>
      <pubDate>Tue, 06 May 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720003-south-korea-approves-record-number-of-biosimilars-in-2024</link>
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        <media:title type="plain">Approved stamp</media:title>
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    <item>
      <title>South Korea approves record number of biosimilars in 2024</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.]]>
      </description>
      <guid>http://www.bioworld.com/articles/719694</guid>
      <pubDate>Wed, 30 Apr 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/719694-south-korea-approves-record-number-of-biosimilars-in-2024</link>
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        <media:title type="plain">Approved stamp</media:title>
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      <title>FDA clears Artrya’s AI-based coronary anatomy software</title>
      <description>
        <![CDATA[The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718655</guid>
      <pubDate>Thu, 03 Apr 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718655-fda-clears-artryas-ai-based-coronary-anatomy-software</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2025/Salix-Coronary-Artery-3apr25.webp?t=1743715402" type="image/jpeg" medium="image" fileSize="165563">
        <media:title type="plain">Salix Coronary Artery</media:title>
        <media:description type="plain">Artrya Ltd’s Salix Coronary Anatomy software analyzes coronary computed tomography angiogram scans via AI to diagnose coronary artery disease.</media:description>
      </media:content>
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    <item>
      <title>IMDRF mimics tri-agency approach to good machine learning practices</title>
      <description>
        <![CDATA[A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.]]>
      </description>
      <guid>http://www.bioworld.com/articles/716482</guid>
      <pubDate>Fri, 31 Jan 2025 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716482-imdrf-mimics-tri-agency-approach-to-good-machine-learning-practices</link>
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        <media:title type="plain">Gears with regulatory words</media:title>
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    <item>
      <title>Ayble Health’s AI-enabled digital care platform for GI conditions</title>
      <description>
        <![CDATA[In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/716479</guid>
      <pubDate>Fri, 31 Jan 2025 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716479-ayble-healths-ai-enabled-digital-care-platform-for-gi-conditions</link>
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        <media:title type="plain">Ayble Health</media:title>
        <media:description type="plain">WO2025015082-A1, “Individualized management system for treating disease, including GI diseases, and methods of use thereof.”Assignee: Ayble Health Inc.Inventors: Jactel, Samuel, N.; Olson, Joseph, M.; Lupe, Stephen, E.; Taft, Tiffany, N.; Fisher, Jennifer, H.IPC codes: A61B 5/00; G16H 40/67; G16H 50/20; G16H 10/60; G16H 20/00; G16H 50/70; G16H 10/20Publication date: Jan. 16, 2025 (also published as US20250022560-A1)Earliest priority details: US2023349700, July 10, 2023</media:description>
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      <title>Blinklab digital app could change how autism is diagnosed</title>
      <description>
        <![CDATA[Children with autism spectrum disorder (ASD) often must wait years before they get a diagnosis, and that wait time can result in missed opportunities for changing behaviors associated with autism.]]>
      </description>
      <guid>http://www.bioworld.com/articles/713416</guid>
      <pubDate>Fri, 25 Oct 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/713416-blinklab-digital-app-could-change-how-autism-is-diagnosed</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/BlinkLab-Test-24oct24.webp?t=1729891503" type="image/jpeg" medium="image" fileSize="231764">
        <media:title type="plain">BlinkLab Test</media:title>
        <media:description type="plain">Blinklab Ltd.’s digital app for diagnosing autism spectrum disorder; credit: Blinklab Ltd.</media:description>
      </media:content>
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    <item>
      <title>AI Medi Scan develops at-home melanoma detection app</title>
      <description>
        <![CDATA[Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712845</guid>
      <pubDate>Tue, 24 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712845-ai-medi-scan-develops-at-home-melanoma-detection-app</link>
      <media:content url="https://www.bioworld.com/ext/resources/BWS/BWS-library/NIH-NCI-Melanoma-cells.webp?t=1669220295" type="image/png" medium="image" fileSize="1942211">
        <media:title type="plain">Melanoma cells stained with an H &amp; E stain and magnified to 320x.</media:title>
        <media:description type="plain">Human metastatic melanoma cells. Credit: Lance Liotta Laboratory/National Cancer Institute, NIH</media:description>
      </media:content>
    </item>
    <item>
      <title>AI Medi Scan develops at-home melanoma detection app</title>
      <description>
        <![CDATA[Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712264</guid>
      <pubDate>Thu, 19 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712264-ai-medi-scan-develops-at-home-melanoma-detection-app</link>
      <media:content url="https://www.bioworld.com/ext/resources/BWS/BWS-library/NIH-NCI-Melanoma-cells.webp?t=1669220295" type="image/png" medium="image" fileSize="1942211">
        <media:title type="plain">Melanoma cells stained with an H &amp; E stain and magnified to 320x.</media:title>
        <media:description type="plain">Human metastatic melanoma cells. Credit: Lance Liotta Laboratory/National Cancer Institute, NIH</media:description>
      </media:content>
    </item>
    <item>
      <title>Neudive advances game-like digital therapeutic for autism</title>
      <description>
        <![CDATA[Seoul, South Korea-based Neudive Inc. is advancing a game-like digital therapeutic called Buddy-in as a software solution for children and adolescents with autism spectrum disorder to practice and improve social skills.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711960</guid>
      <pubDate>Fri, 06 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711960-neudive-advances-game-like-digital-therapeutic-for-autism</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/Neudive-6sept24.webp?t=1725658063" type="image/jpeg" medium="image" fileSize="113947">
        <media:title type="plain">Neudive</media:title>
      </media:content>
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    <item>
      <title>Asian med-tech industry poised to grow to $225B by 2030</title>
      <description>
        <![CDATA[A decade ago, when Asia Pacific Medical Technology Chairman (APACMed) John Collings was running a medtech business in China, he was flying high with multiple rounds of investment under his belt and preparing to launch two new technologies, but the company hit a regulatory hurdle that delayed the launch and he found himself grappling for answers, he told the APACMed Forum held Sept. 5 in Singapore.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711952</guid>
      <pubDate>Thu, 05 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711952-asian-med-tech-industry-poised-to-grow-to-225b-by-2030</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/APACMed-Chairman-John-Collings-5sept24.webp?t=1725569551" type="image/jpeg" medium="image" fileSize="218468">
        <media:title type="plain">APACMed Chairman John Collings</media:title>
        <media:description type="plain">APACMed Chairman John Collings</media:description>
      </media:content>
    </item>
    <item>
      <title>Korea taps into AI, DTx boom with new approvals, investments</title>
      <description>
        <![CDATA[South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707594</guid>
      <pubDate>Wed, 24 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707594-korea-taps-into-ai-dtx-boom-with-new-approvals-investments</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/K-DTx_VIVIDBrain-4-24.webp?t=1713991485" type="image/jpeg" medium="image" fileSize="86180">
        <media:title type="plain">K DTx VIVIDBrain</media:title>
        <media:description type="plain">K-DTx VIVIDBrain. Credit: KHIDI</media:description>
      </media:content>
    </item>
    <item>
      <title>FDA, industry coalition still at odds over September 2022 CDS final guidance</title>
      <description>
        <![CDATA[The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.]]>
      </description>
      <guid>http://www.bioworld.com/articles/697821</guid>
      <pubDate>Fri, 09 Jun 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/697821-fda-industry-coalition-still-at-odds-over-september-2022-cds-final-guidance</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Research-and-science/Clinical-research.webp?t=1588871340" type="image/png" medium="image" fileSize="374194">
        <media:title type="plain">Health professional reviewing digital health data</media:title>
      </media:content>
    </item>
    <item>
      <title>Cognetivity works to expand awareness, potential uses of brain health test</title>
      <description>
        <![CDATA[Cognetivity Neurosciences Ltd. is making progress in promoting its cognitive assessment tool as the brain health equivalent of a blood pressure check, following feedback from clinicians indicating the test could have broad applicability.]]>
      </description>
      <guid>http://www.bioworld.com/articles/521251</guid>
      <pubDate>Tue, 02 Aug 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/521251-cognetivity-works-to-expand-awareness-potential-uses-of-brain-health-test</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Neurology/Alzheimers-illustration.webp?t=1604527274" type="image/png" medium="image" fileSize="407999">
        <media:title type="plain">Elderly hands holding broken brain structure</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software </title>
      <description>
        <![CDATA[The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told <em>BioWorld</em>.]]>
      </description>
      <guid>http://www.bioworld.com/articles/520081</guid>
      <pubDate>Fri, 24 Jun 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520081-fda-rejects-artryas-510k-for-its-ai-enabled-salix-coronary-anatomy-software</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/FDA--not-approved-stamp.webp?t=1588869827" type="image/png" medium="image" fileSize="209674">
        <media:title type="plain">FDA Not Approved stamp</media:title>
      </media:content>
    </item>
    <item>
      <title>Brazil readies to adopt SaMD regulation</title>
      <description>
        <![CDATA[Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.]]>
      </description>
      <guid>http://www.bioworld.com/articles/519257</guid>
      <pubDate>Fri, 27 May 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/519257-brazil-readies-to-adopt-samd-regulation</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/South-America/Brazil-flag.webp?t=1588688582" type="image/png" medium="image" fileSize="472983">
        <media:title type="plain">Brazilian flag</media:title>
      </media:content>
    </item>
    <item>
      <title>Singapore updates guidelines for software as medical devices to expand scope</title>
      <description>
        <![CDATA[Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/519037</guid>
      <pubDate>Fri, 20 May 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/519037-singapore-updates-guidelines-for-software-as-medical-devices-to-expand-scope</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Asia/asia-singapore.webp?t=1588615605" type="image/png" medium="image" fileSize="388073">
        <media:title type="plain">Singapore</media:title>
      </media:content>
    </item>
    <item>
      <title>Pfizer in bid to acquire digital health company Resapp for AU$100M</title>
      <description>
        <![CDATA[Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.]]>
      </description>
      <guid>http://www.bioworld.com/articles/517862</guid>
      <pubDate>Tue, 12 Apr 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/517862-pfizer-in-bid-to-acquire-digital-health-company-resapp-for-au100m</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Australia/Australia-digital-circuit-network.webp?t=1611351726" type="image/png" medium="image" fileSize="1500329">
        <media:title type="plain">Map of Australia as blue circuit board, digital network</media:title>
      </media:content>
    </item>
    <item>
      <title>Resapp’s stand-alone cough counter app cleared in Australia and Europe</title>
      <description>
        <![CDATA[PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.]]>
      </description>
      <guid>http://www.bioworld.com/articles/514674</guid>
      <pubDate>Wed, 29 Dec 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/514674-resapps-stand-alone-cough-counter-app-cleared-in-australia-and-europe</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Respiratory/respiratory-cough-phone-telehealth.webp?t=1745266993" type="image/jpeg" medium="image" fileSize="214399">
        <media:title type="plain">Woman holding smartphone coughing</media:title>
      </media:content>
    </item>
    <item>
      <title>New FDA draft guidance seen as vital for digital companies new to regulation</title>
      <description>
        <![CDATA[The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.]]>
      </description>
      <guid>http://www.bioworld.com/articles/513338</guid>
      <pubDate>Fri, 12 Nov 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/513338-new-fda-draft-guidance-seen-as-vital-for-digital-companies-new-to-regulation</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/FDA-icons.webp?t=1588870105" type="image/png" medium="image" fileSize="458141">
        <media:title type="plain">FDA icons</media:title>
      </media:content>
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    <item>
      <title>Airdoc stumbles with Hong Kong IPO</title>
      <description>
        <![CDATA[Beijing Airdoc Technology Co. Ltd. raised HK$1.67 billion (US$214.8 million) with its IPO on the Hong Kong Exchange (HKEX) on Nov. 5, falling below its expectations of a $500 million raise. Share prices for the artificial intelligence-based (AI) medical imaging firm were priced at HK$75.10 apiece and dropped 3.5% to HK$72.50.]]>
      </description>
      <guid>http://www.bioworld.com/articles/513091</guid>
      <pubDate>Fri, 05 Nov 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/513091-airdoc-stumbles-with-hong-kong-ipo</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/11-05-Airdoc.webp?t=1636148678" type="image/png" medium="image" fileSize="418092">
        <media:title type="plain">Airdoc products, concept image</media:title>
        <media:description type="plain">Airdoc provides AI-empowered retina-based early detection, diagnosis, and health risk assessment solutions, including software as medical devices as well as hardware devices. Credit: Beijing Airdoc Technology Co. Ltd. </media:description>
      </media:content>
    </item>
    <item>
      <title>AI or crystal ball? Panel predicts the future of digital health post-pandemic</title>
      <description>
        <![CDATA[Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512036</guid>
      <pubDate>Mon, 04 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512036-ai-or-crystal-ball-panel-predicts-the-future-of-digital-health-post-pandemic</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/connected-digital-health.webp?t=1589385444" type="image/png" medium="image" fileSize="397881">
        <media:title type="plain">Laptop, stethoscope, medical icons, health professional</media:title>
      </media:content>
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      <title>MHRA eyes overhaul of regulation of medical devices, SaMD and artificial intelligence </title>
      <description>
        <![CDATA[The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.]]>
      </description>
      <guid>http://www.bioworld.com/articles/511650</guid>
      <pubDate>Tue, 21 Sep 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/511650-mhra-eyes-overhaul-of-regulation-of-medical-devices-samd-and-artificial-intelligence</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/europe-map.webp?t=1588688099" type="image/png" medium="image" fileSize="511811">
        <media:title type="plain">Map of Europe</media:title>
      </media:content>
    </item>
    <item>
      <title>Guidance still lacking for AI, but existing standards, other guidances a good roadmap</title>
      <description>
        <![CDATA[There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.]]>
      </description>
      <guid>http://www.bioworld.com/articles/511345</guid>
      <pubDate>Mon, 13 Sep 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/511345-guidance-still-lacking-for-ai-but-existing-standards-other-guidances-a-good-roadmap</link>
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    <item>
      <title>Australia issues new regs for software-based medical devices that may change classifications</title>
      <description>
        <![CDATA[PERTH, Australia &ndash; Australia&rsquo;s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of devices currently on the market, and these devices will need to be re-registered if they are to stay on the market.]]>
      </description>
      <guid>http://www.bioworld.com/articles/510532</guid>
      <pubDate>Tue, 17 Aug 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/510532-australia-issues-new-regs-for-software-based-medical-devices-that-may-change-classifications</link>
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    <item>
      <title>Australia releases new regulations on software-based medical devices</title>
      <description>
        <![CDATA[PERTH, Australia &ndash; Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices.]]>
      </description>
      <guid>http://www.bioworld.com/articles/502728</guid>
      <pubDate>Fri, 22 Jan 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/502728-australia-releases-new-regulations-on-software-based-medical-devices</link>
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        <media:title type="plain">Map of Australia as blue circuit board, digital network</media:title>
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    </item>
    <item>
      <title>FDA promises a draft guidance for change control for artificial intelligence in 2021</title>
      <description>
        <![CDATA[The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year &ndash; perhaps longer &ndash; of uncertainty as to how to handle change control for their algorithms.]]>
      </description>
      <guid>http://www.bioworld.com/articles/502330</guid>
      <pubDate>Tue, 12 Jan 2021 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/502330-fda-promises-a-draft-guidance-for-change-control-for-artificial-intelligence-in-2021</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/AI/AI-digital-health.webp?t=1683125967" type="image/jpeg" medium="image" fileSize="229937">
        <media:title type="plain">Artificial intelligence and digital health icons</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA enforcement discretion for digital health a source of uncertainty for industry</title>
      <description>
        <![CDATA[The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law &amp; Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies.]]>
      </description>
      <guid>http://www.bioworld.com/articles/501811</guid>
      <pubDate>Mon, 28 Dec 2020 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/501811-fda-enforcement-discretion-for-digital-health-a-source-of-uncertainty-for-industry</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Devices/connected-digital-health.webp?t=1589385444" type="image/png" medium="image" fileSize="397881">
        <media:title type="plain">Laptop, stethoscope, medical icons, health professional</media:title>
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