Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March. Read More
Exor NV’s acquisition of a 15% stake in Royal Philips NV for approximately €2.6 billion (US$2.8 billion), is a boon for the health care tech company which has been suffering in recent years on the back of a product recall controversy. Netherlands-based diversified holding company Exor will become Philips’ biggest shareholder, and said it is committed to being a “long-term minority investor,” as it grows its investment in the health care sector. Read More
Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment. Read More
Peijia Medical Co. Ltd. reported the implant of its Taurustrio transcatheter aortic valve replacement (TAVR) system in a first patient as part of a multi-center trial getting one step closer to launching the first TAVR system for aortic regurgitation (AR) in China. Read More
Mdoloris Medical Systems SAS reported it has developed an automated system for regulating perioperative pain based on continuous optimization of parasympathetic tone. Closed-loop control systems are still rare in the anesthesia space, but they provide greater reliability in achieving set objectives, reduce the risk of human error and free the anesthesiologist from the burden of manually adapting the administration of the various therapies required for surgery. Read More
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld. Read More
The Biden administration recently announced an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with FDA regulation of medical device cybersecurity. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Alter G, Clario, Endra Life Sciences, Microbot Medical, Rewalk Robotics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Delcath Systems, Foundation Medicine, Tempus Labs. Read More
