As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of remote audits to fill in for live MDSAP inspections. This program has been renewed again through the end of September 2022, but the sponsoring regulatory agencies said this will be the last extension, barring exceptional circumstances.
Device servicing by third parties has been topical of late, although not in the context of continuous positive airway pressure (CPAP) systems. That seems likely to change thanks to the ongoing recall of CPAP machines made by Philips Respironics Inc., of Murrysville, Pa., which was driven by reports of degradation of foam used in the device for insulation.
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers.
Varian Medical Systems Inc. received an investigational device exemption (IDE) from the U.S. FDA to start a clinical trial evaluating its new radiation therapy. The experimental treatment, named Flash, delivers radiation at ultra-high dose rates, typically in less than one second. The Siemens Healthineers AG company said the therapy is capable of being over 100 times faster than conventional radiation therapy.
The U.S. FDA posted an updated safety communication regarding pulse oximetry accuracy with an eye toward those with darker skin pigmentation, a problem that has surfaced in the medical literature. The FDA said it intends to convene an advisory committee hearing later this year, suggesting that more strict performance standards for pulse oximeters are on the way.
Sounds like Eargo Inc. received good news as Patient Square Capital signed a definitive agreement to purchase $100 million in senior secured convertible notes plus an additional $25 million in future investment subject to certain conditions. The new funds provide some breathing room for the hearing aid company, which has been rocked by a $34.37 million settlement with the Department of Justice (DOJ), questions about its ability to remain on the Nasdaq exchange following delayed filings of its 2021 annual report and first quarter 2022 report and a 97% drop in its stock price since its high in February 2021.
Sarepta Therapeutics Inc. aims to resolve “very quickly” the clinical hold placed by the U.S. FDA on SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy (DMD), said Louise Rodino-Klapac, chief scientific officer.
Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a severe gunshot wound to the leg and the other was injured by shrapnel.
Medtronic plc has received U.S. FDA 510(k) clearance and breakthrough device designation for its Ligapass 2.0 ligament augmentation system in spine surgery. The surgical treatment is designed to reduce the reoperation rate for proximal junctional kyphosis (PJK), a complication of adult spinal deformity surgery which disrupts spinal ligaments. Ligament augmentation provides strength to the upper instrumented vertebra and adjacent segments while also reducing junctional stress at those levels.
The U.S. FDA reported a class I recall for a single lot of the Safestar 55 breathing filter system by Draeger Inc., due to partial obstruction of the filter, which can lead to hypoxia. The affected units were part of a lot that was to be destroyed, but were instead inadvertently distributed even though they were identified as unusable after a manual inspection process at Draeger.
