It’s been more than a year since COVID-19 initially smacked humanity and as BioWorld’s senior analyst, Karen Carey, detailed in early February, vaccine and therapeutic R&D continues to move furiously forward. Variants have added a new twist in the race to gain global control of the virus. But what about tests and surveillance? Are these medical technologies keeping pace with the rapidly changing virus? BioWorld MedTech takes a deep dive in today’s edition.
Staff Writer Meg Bryant looks for answers on whether current tests are effective when it comes to the variants and how the test makers are adapting.
Staff Writer Annette Boyle explores how industry and universities united to scale up surveillance of SARS-CoV-2 variants.
Senior Science Editor Anette Breindl explains why mutations in SARS-CoV-2 are at once a challenge, a fact of life and an opportunity.
Regulatory Editor Mark McCarty highlights how governments are being challenged with keeping track of mutations while simultaneously validating new and revamped existing tests.
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.
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.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveo, Cardiacsense, Kantaro, Surgical Planning Associates, Visby.
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