All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Biosimilars
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Radiopharmaceuticals
    • Science '22 in Review
    • Top Biopharma Trends of 2022
    • Top Med-tech Trends of 2022
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • sign in
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, June 8, 2023
Breaking News: Try BioWorld for free for two weeksBreaking News: Try BioWorld for free for two weeksBreaking News: Try BioWorld for free for two weeks
  • CLAAS left atrial appendage occluder

    Conformal seals $35M series D for ‘CLAASy’ LAAO device

    Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
  • Sparrow’s smartphone stethoscope gets FDA nod

  • Today's news in brief

  • Conformal seals $35M series D for ‘CLAASy’ LAAO device

    Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
  • Sparrow’s smartphone stethoscope gets FDA nod

    The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
  • Today's news in brief

    BioWorld MedTech briefs for June 7, 2023.
  • Committee set up in France to assess diagnostic, prognostic and predictive technology

    The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
  • FDA warning letters hint that med-tech compliance programs drifted during COVID

    The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
  • US Medicare program renders ‘landmark’ coverage memo for seat elevation devices

    The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.

BioWorld Insider Podcast

Preventing opioid overdoses with a smart patch: Resilient Lifescience Inc. is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

Listen now

Digital health

  • Map of Europe

    Digital therapeutics seen as effective, but reimbursement slow to materialize

    Europe
    There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
  • Exai Bio MCED test shows high sensitivity for stage I cancer, machine learning detects gastric cancer

    Conferences
    Breakthroughs in early detection of cancer offer increasing hope for better outcomes and longer lives for individuals affected by malignancies. This year’s American Society of Clinical Oncology annual meeting highlighted strong results from several companies at the forefront of this potential...
  • digital health

    China ramps up efforts to digitize health

    Regulatory
    China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow...
  • Machine-Models-5-31.jpg

    Machine models enhance cardiac surgery mortality risk prediction

    Cardiovascular
    Researchers at Mount Sinai Hospital have demonstrated that a machine learning-based model enables medical institutions to predict mortality risk for individual cardiac surgery patients.
More in Digital health

Today's news in brief

  • Appointments and advancements for June 7, 2023

  • Financings for June 7, 2023

  • In the clinic for June 7, 2023

  • Other news to note for June 7, 2023

  • Regulatory actions for June 7, 2023

Regulatory

  • Abiomed’s fix for purge issues in some Impella 5.5 units falters

  • Sea-Long Medical says FDA inspection ‘a good learning experience’

  • Philips and Masimo receive FDA clearance for advanced monitoring

  • Orlucent receives breakthrough device designation for hand-held mole imaging system

  • US debt ceiling deal would flat-line NIH, FDA appropriations in fiscal 2024

  • SCOTUS: Belief, not interpretation, at heart of FCA violations

  • NICE sees evidence gaps for MRI-ultrasound fusion prostate biopsy systems

  • GE Healthcare wins FDA OK for Precision DL PET/CT image processing software

  • US surgeon agrees to pay $43M for unperformed vascular procedures

  • FDA wraps up morcellation containment bag guidance, containment use still down

Financings

  • Green arrow up red arrow down

    Follow-on offerings up year-over-year as overall med-tech financing value continues decline

    Analysis and data insight
    Med-tech companies raised $8.65 billion in the first five months of the year, a decrease of 34.9% from the $13.29 billion raised in the same time frame last year. The number of deals is down 33.04% from last year, from 230 to 154.
  • Gasp! Wesper challenges polysomnography with wireless, portable sleep lab

    Clinical
  • Brightheart raises €2M for software to detect congenital heart defects in fetuses

    Cardiovascular
  • Tissium raises $54M for launch of programmable products for tissue reconstruction

    Europe
  • Reddress lands $26M for autologous wound management system

    Clinical
More in Financings
black cortellis ad

Newco news

  • Lab research with pipette, microsope

    Orakl developing in vitro diagnostic test using organoids for colorectal cancer

    Cancer
    The Gustave Roussy cancer center, specializing in cancer treatment, and its technology transfer subsidiary Gustave Roussy Transfert, reported the creation of startup Orakl SA, which develops a technology for modeling cancer tumors called the patient tumor avatar. Orakl leverages a unique collection...
  • Startup Enhanc3D raises £10M for high-res genome mapping platform

    Medical devices and technologies
    Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.
  • Spinoffs keep up dizzying pace with Medtronic separation

    U.S.
    After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected...
  • Axoft launches with $8M for brain-machine interface implants

    Financings
  • Quark Biosciences spins out cancer liquid biopsy company Pharus Diagnostics

    Asia-Pacific
  • Ampel’s genomic blood test detects and predicts severity of COVID-19

    Coronavirus
  • Curimeta launches partnership to unlock real-world data

    Financings
More in Newco news

Deals and M&A

  • Mallya sensor on insulin pen

    Novo Nordisk negotiating takeover of insulin pen maker Biocorp

    Diabetes
    Novo Nordisk A/S has entered into exclusive negotiations for a controlling stake in Biocorp SA, suppliers of Mallya, a Bluetooth-enabled smart add-on device for insulin pen injectors. The takeover will be phased over several stages. Novo Nordisk has initially negotiated with Bio Jag SAS, Biocorp’s...
  • Acquisition puzzle

    Avacta acquires Coris for £7.4M as it builds diagnostics business

    Diagnostics
    Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch...
  • Freenome buys immunodiagnostics company Oncimmune for $16M

    Acquisition
    Freenome Inc. has acquired U.K.-based immunodiagnostics developer Oncimmune Ltd. for £13 million (US$16 million), in a move that bolsters Freenome’s frontline early cancer detection efforts. While Freenome has been largely focused on getting the U.S. FDA’s nod for its colorectal cancer test,...
  • Hand holding piece of pie chart

    Pear sliced into four parts at auction for $6M

    Digital health
    A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT...
  • Boston Scientific abandons $230M purchase of M.I. Tech due to pressure from regulators

    U.S.
    Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national...
More in Deals and M&A

U.S.

  • Galleri showcases Grail’s MCED technology in real-world setting

  • US House committee taking aim at TRIPS waivers for COVID therapies, tests

  • Hopes for increased appropriations for FDA, NIH not necessarily lost

  • Locate Bio receives breakthrough nod for Ldgraft spine fusion system

  • US Federal Circuit sides with Teleflex in catheter patent scrum with Medtronic

  • Sequana considers listing in the US as it looks for growth for Alfapump

  • Thermo Fisher receives clearance for predictive immunoassay for preeclampsia

  • US-based distributor hit with $487M judgment in False Claims Act case

  • Philips says third-party CPAP machine testing indicates harm from degraded foam is unlikely

  • FDA-cleared Paradigm designed to replace traditional surgical navigation systems

Europe

  • U.K. flag on stethoscope

    Reports says UK government needs to speed up approval of med-tech devices

    Regulatory
    The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of...
  • UK investing £121M to revive clinical trial activity as part of overall life sciences boost

    Clinical
  • GPT-based algorithm shown to improve trauma monitoring

  • Metafora’s diagnostic test now reimbursed in France under innovation initiative

  • EU legislation and coverage issues prompting industry to ask whether AI is worth the trouble

    Regulatory
More in Europe
black cortellis ad

Asia-Pacific

  • endoangel.jpg

    Endoangel’s AI-based diagnosis system for endoscopy is approved in China

    Regulatory
    Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
  • China grants marketing approval for a hybrid intravascular imaging system

    Regulatory
    Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
  • BIO Korea 2023: South Korean government funds keep innovators afloat during VC deep freeze

    The venture capital market in South Korea is frozen shut, said presenters during the recent BIO Korea 2023 conference in Seoul, but Korea’s Medical Device Development Fund will help support domestic R&D efforts to the tune of ₩987 billion (US$738 million) over five years.
  • China greenlights Happiness Workshop’s disposable soft ureteroscope

    Regulatory
  • Acotec’s microcatheter wins Chinese approval for interventional treatment

    China
  • Roche’s anti-PRAME antibody launched in China for melanoma diagnosis

    China
  • Meio hopes for expedited approval for its Titian robot for cardiac electrophysiology

    Robotic surgery
More in Asia-Pacific

Clinical

  • Creo’s Microblate Flex poised to provide early lung cancer detection

    Cancer
    Creo Medical Group plc says it is poised to address the mismatch between the advances in screening technology, which are making it possible to detect early-stage lung cancer, and the current invasive and inappropriate methods of treating it,...
  • Biosency’s technology detects acute chronic obstructive pulmonary disease early

    Respiratory
    Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show...
  • Treatment with Endogenex device eliminates the need for insulin in type 2 diabetes

    Diabetes
    A one-hour procedure pioneered by Endogenex Inc. could make insulin use obsolete in people with type 2 diabetes. The recellularization via electroporation therapy (ReCET) procedure uses a specialized catheter to deliver electric pulses to the...
  • Study shows Exact benefit of early cancer diagnosis

    Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers...
  • Renal denervation, the comeback kid

    Renal denervation (RDN) was described as the “comeback kid” at the recent EuroPCR conference in Paris where participants argued that following the success seen in several sham-controlled trials, there is now no doubt about the safety and the...
  • Magnus Medical’s Saint system alters brain signals in patients with severe depression

    Results from a new study suggest that treatment with Magnus Medical Inc.'s Saint neuromodulation system causes abnormal brain signals to become normal by reversing the direction brain signals flow in severely depressed individuals. The researchers...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • Preventing opioid overdoses with a smart patch
  • Better times ahead for the biopharma sector? Could be, the new numbers say
  • Radiopharmaceuticals: The next big disrupter?
  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal
  • Psychedelic evolution: Mindset Pharma looks to change mental health treatment
  • $1B+ biopharma deals keep values afloat, even amid muted volume
  • Extending the human lifespan
  • New therapies vie to change fatal course of amyotrophic lateral sclerosis

View all

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years
Subscribe

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years
Subscribe

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region
Subscribe

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages
Subscribe

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription
Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing