Delcath Systems Inc.’s stock was up 114.43% today after the U.S. FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma. The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March. The New York-based interventional oncology company plans to launch Hepzato in the fourth quarter at 10 treatment sites, including three Expanded Access Program sites.

Exor picks up 15% of Philips as it grows health and tech investment

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.

Boston Scientific scores another win for Polarx with FDA approval

Boston Scientific Corp., of Marlborough, Mass., 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.

Mdoloris unveils closed-loop analgesia system for perioperative care

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 anesthesia, 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. “We have reached a major milestone in the control of perioperative nociception. This achievement marks a world first in the development of an automated system for perioperative pain regulation,” Fabien Pagniez, CEO and founder of Mdoloris, told BioWorld.

Peijia admits first patient in trial of Taurustrio TAVR system

Peijia Medical Ltd., a maker of transcatheter valve therapeutic and neuro-interventional procedural devices, implanted 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. The trial aims to evaluate Taurustrio to treat patients with native symptomatic and severe AR. These patients are usually at high or greater risk for surgical aortic valve replacement. Peijia will include data from this clinical trial in its registration application to China’s NMPA.

Biden administration proposes government-wide cybersecurity regulatory harmonization

The Biden administration recently reported an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with U.S. FDA regulation of medical device cybersecurity. While the White House explicitly acknowledged the need for avoidance of duplicative regulation, the emphasis on critical infrastructure, including cloud services, could implicate health data repositories that are used by digital health apps and electronic health records, raising the specter of additional regulatory hurdles for makers of these products.

Prizes in place of Rx patents not the cure needed

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, David Kappos, board co-chair of the Council for Innovation Promotion, told BioWorld. Other symptoms such as the European Commission’s proposed compulsory licensing initiative and the World Trade Organization’s COVID-19 IP waivers have intensified in the wake of the pandemic, as policymakers blamed patents for inequitable global access to vaccines, tests and treatments. While supply chain problems, pricing and reimbursement issues need to be addressed, they will not be resolved by curtailing patents, Kappos said.

Also in the news:

Endra Life Sciences, Medalliance, Microbot Medical, Invitae, ReWalk Robotics, Rokit Healthcare, Acumen, Enspire, Delcath Systems, Foundationone, Tempus Labs