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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 13, 2019

View Archived Issues
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FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite. Read More
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Following solid quarterly results, Hologic gains FDA nod for 3Dquorum imaging tech

Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said. Read More

NIH-backed Medicasafe aims for FDA clearance of opioid use disorder drug-device combo

Drug addiction has often proven resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of these drugs. Read More
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TGA asked to hold off on device reclassification pending implementation of EU's MDR

Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA. Read More

Aussie device makers urge TGA to follow IMDRF lead on software regulations

Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification. Read More

Introducing the new BioWorld.com

For more than two decades, the BioWorld team has understood that there's a vital need to know to stay competitive, to bring your novel ideas forward through the long cycle of development, testing and commercialization. Now we've upgraded our presentation of news and analysis. On Nov. 19, we're migrating to a fantastic new platform. Read More

Financings for Nov. 13, 2019

Med-tech firms raising money in public or private financings. Read More

Regulatory front for Nov. 13, 2019

The latest global regulatory news, changes and updates affecting medical devices and technologies. Read More

Other news to note for Nov. 13, 2019

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Appointments and advancements for Nov. 13, 2019

New hires and promotions in the med-tech industry. Read More

In the clinic for Nov. 13, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Regulatory actions for Nov. 13, 2019

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

BioWorld MedTech's Oncology Extra

Keeping you up to date on recent developments in oncology. Read More

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