Patient-centered predictive health company Sema4 said Wednesday it has inked a merger agreement with CM Life Sciences, a special purpose acquisition company led by Casdin Capital and Corvex Management. Upon closing, CM Life Sciences will be renamed and its common stock listed on the Nasdaq global market under a name and ticker symbol yet to be announced. Read More
Diagnostic manufacturers are turning their attention to antibodies for those who have been vaccinated for the SARS-CoV-2 virus, and the U.S. FDA’s Tim Stenzel had some advice about this on the Feb. 10 testing town hall. Stenzel advised that developers think of such tests in the same vein as a companion diagnostic (CDx) in that these antibody test will have to be separately validated for each vaccine that is included in the test’s labeled claims. Read More
LONDON – It began life as a legal tidy-up of post-Brexit regulatory issues, but the Medicines and Medical Devices bill that emerged from its final reading last week is in a significantly different form. Most notably, the bill legislates for the creation of a national register of all implantable medical devices and the appointment of a patient safety commissioner to act a single port of call and advocate for patients when devices fail. Read More
Personal Genome Diagnostics Inc. (PGDx) secured $103 million in a series C fundraising round led by Cowen Healthcare Investments and other stars of the med-tech investment world. Participants included Northpond Ventures, Vensana Capital, Rock Springs Capital, Kern Capital, Sands Capital, PFM Health Sciences, Windham Ventures, New Enterprise Associates, Innovatus Capital Partners, Catalio Capital Management, and others. Read More
PARIS – Ecential Robotics SAS has just secured $120 million series C funding in equity and debt financing, to support the manufacturing and commercial development of its robotic platform for spinal surgery. This is the largest financial transaction undertaken by any med-tech company in France. Read More
New hires and promotions in the med-tech industry, including: Acutus Medical, Aver, Beta Bionics, Henry Schein, Optimdosing, Worldwide Clinical Trials. Read More
Med-tech firms raising money in public or private financings, including: Equip, Evaxion Biotech, Lucira Health, Pacific Biosciences of California. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveo, Cardiacsense, Kantaro, Surgical Planning Associates, Visby. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS posts request for information for Lyme diagnostics; NICE: Stak device backed by one 35-enrollee study. Read More
Keeping you up to date on recent developments in orthopedics, including: Hot nano-chisel used to create artificial bones in a Petri dish; A 'skeletal age' calculator to predict bone fracture risk; Fetal surgery for spina bifida leads to better mobility in school-age children. Read More
