Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
The U.S. FDA has granted 510(k) clearance to a blood-based biomarker assay for disease monitoring of patients with metastatic breast cancer (MBC). The Divitum Tka assay, developed by Uppsala, Sweden-based Biovica International AB, measures the activity of the enzyme thymidine kinase-1 (TK1) which is highly associated with cell proliferation and a predictive marker of tumor aggressiveness. It is the first liquid cancer cell proliferation biomarker assay to be approved by the FDA for use in monitoring metastatic breast cancer.
Med tech patents have been especially vulnerable to litigation in recent years, and a new decision by the Court of Appeals for the Federal Circuit affirms yet again the vulnerability of patents undergoing litigation. The Federal Circuit said nine claims found in two patents held by Becon Medical Ltd., of Batavia, Ill., were invalid due to obviousness, presenting the company a significant loss in its infringement litigation with Talexmedical LLC, of Malvern, Pa.
While the U.S. Senate Finance Committee is ostensibly investigating how big pharma is using the 2017 tax changes to avoid paying its fair share of U.S. taxes, at least one medical device company has been drawn into the probe and is being scolded for not cooperating.
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.
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.
The U.S. Department of Justice (DOJ) reported that Biotronik Inc., of Lake Oswego, Ore., agreed to pay $12.95 million to settle allegations that the company induced cardiologists to use the company’s devices to treat their patients. Among the allegations is that the company paid for physicians’ holiday parties and winery tours that could not be tied to a legitimate business expense.
Several U.S. government agencies have been involved in the enforcement action directed toward Medifirst Solutions Inc., of Freehold, N.J., including the Department of Justice, but the Securities and Exchange Commission (SEC) has had its say as well. The SEC recently announced that a final consent judgment has been entered against a former Medifirst stock promoter, although there is still no word as to the fate of the company’s former CEO.
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