DUBLIN – Liquid biopsy developer Freenome Inc. has – literally – capitalized on its recent proof-of-concept AI-Emerge colorectal cancer (CRC) screening study by raising $270 million in a series C round that will enable the South San Francisco firm to complete its ongoing Preempt CRC registration study and to file for pre-market approval from the FDA. Read More
Hologic Inc., which focuses on women's health, reported Aug. 25 that it was acquiring Acessa Health Inc., a company that has developed a minimally invasive treatment for fibroids. It is offering about $80 million in cash plus contingent payments based on future revenue growth. Read More
The U.S. FDA has given the green light to a new type of treatment to help smokers quit, clearing the way for the first time the use of deep transcranial magnetic stimulation (Deep TMS) for short-term smoking cessation in adults. Read More
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame. Read More
A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing. Read More
Regenerative therapies startup Jointechlabs Inc. has won the U.S. FDA’s nod for its MiniTC point-of-care fat tissue processing device. The 510(k)-cleared product is designed to extract microfat for use in grafts for a variety of indications, including medical aesthetics, plastic surgery, orthobiologics and wound healing. Read More
New hires and promotions in the med-tech industry, including: Bioiq, Castlelight Health, Emergent Biosolutions, Immunovia, Perimeter Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allstar Health Brands, Altarum Institute, Anteotech, Cambridge Blockchain, Cgn Nuclear Technology Development, Change Healthcare, Consumermedical, Crescent Design, Digital Diagnostics, Freenome, IBA, InfiniteMD, Kicteam, Machine Solutions, Primed Medical Products, Prometheus Analytics, Renalytix AI, Si-Bone, Sleepimage, Teknipure, Tpt Global Tech, Vaxess Technologies, Verndari, Zensark. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fluidigm, Inova, Jointechlabs, Natera, Surgentec. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, HHS. Read More
Keeping you up to date on recent developments in orthopedics, including: Hip fracture risk linked to nanoscale bone inflexibility; High intensity physical activity in early life could lead to stronger bones in adulthood; Xtant Medical reports U.S. launch of the Matriform Si; Opioid prescription rates for knee surgery vary, but higher strength dosage common. Read More
