Integra Lifesciences Holdings Corp. has entered a definitive agreement to acquire regenerative medicine-focused Acell Inc. for an up-front cash payment of $300 million and up to an additional $100 million upon the achievement of certain revenue growth milestones. The deal is expected to close in the first quarter of 2021, subject to the satisfaction of customary conditions. It also comes almost three months after London-based Smith+Nephew plc said it was going to pick up the extremity orthopedics business of Integra for $240 million in cash.
Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.
Keeping you up to date on recent developments in cardiology, including: Genes influencing CAD identified; Education reassures patients with noncardiac chest pain; Skin helps predict heart disease.
Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization from the U.S. FDA for the antibody test.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs.
While telehealth has been gaining traction over the last few years, the COVID-19 pandemic really shined a spotlight on this rapidly rising space. In July, Globaldata predicted that the telehealth industry likely would reach $20 billion by 2024, boosted by a loosening of restrictions. Indeed, an Oct. 30 CDC report highlighted a 154% increase in telehealth visits during the last week of March vs. the same period in 2019. The authors added that policy changes could help boost access to care via telehealth during and after the pandemic.
Keeping you up to date on recent developments in cardiology, including: Addressing concerns regarding pharmacogenetic testing; Improving the nation's heart health; Researchers reveal genetic abnormalities that cause brain aneurysms.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA issues guidance on enforcement policy regarding certain quality standards requirements under MQSA; MHRA looks to provide additional help post-Brexit.
