Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus, Ambu, Biotronik, Rapid Medical.
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
The shortage of semiconductor products has plagued the U.S. medical device industry for better than a year, but there is legislation in play in Washington that might bring some relief. The White House held a July 25 briefing during which President Joseph Biden promised his support for the CHIPS Plus Act of 2022, a development that could break a legislative logjam.
Abbvie Inc. and Istar Medical SA inked a deal to develop and commercialize Istar’s Miniject device to treat patients with primary open-angle glaucoma. The minimally invasive glaucoma surgical (MIGS) device won CE mark approval in November and has been available in some European countries since early 2022.
The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.
3M Co. reported a planned spinoff of its health care business by 2023, during the company’s second quarter earnings. The health care company will operate as a separate public company focused on wound care, health care IT, oral care and biopharma filtration. 3M said the health care business is expected to be spun off with net leverage of approximately 3.0x to 3.5x EBITDA and the ‘New 3M’ company will retain a stake of 19.9% in health care, which will be monetized over time.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Northeast Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arthrex, Berkshire Biomedical, Causalens, Diesse, Exo, Hygieia, Medo, Menarini, Orthofix, Rockley Photonics, Skytron, Vela.
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