The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.
The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly administrative issues associated with this proposal. Several of those who have commented to the docket have expressed misgivings as to the proposed 12-month compliance deadline upon issuance of a final rule.
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
Although it was recently overturned in a legal challenge, a short-lived California state law mandating gender quotas for corporate boards may have made a few drug and device companies based in the state think twice about the makeup of their boards.
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
The full U.S. commercial launch of the UltraguideTFR is intended to crack a market of nearly nine million Americas suffering from a painful condition known as trigger finger, which is caused by the progressive restriction of tendon motion and the ability to bend and straighten the fingers.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
The Senate Health, Education, Labor and Pensions (HELP) Committee has posted its version of U.S. FDA user fee legislation, a bill that echoes many of the primary features of the version already at play in the House of Representatives. One critical difference is that the Senate bill includes legislation that would enable the FDA to regulate lab-developed tests (LDTs), the so-called Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the omission of which from the House bill ruffled a few feathers. The American Clinical Laboratory Association (ACLA) responded to the Senate bill with a May 17 statement applauding the inclusion of the VALID Act in the Senate user fee bill.
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
RSS
