Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome. The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Butterfly Medical wins CE Mark for in-office benign prostate hyperplasia device
Medical device developer Butterfly Medical said today it won CE Mark approval in the European Union for its device designed for the in-office treatment of benign prostate hyperplasia. The Israel-based company’s device is designed to dilate the prostatic urethra without any surgical incisions or prostate tissue removal. The device then secures tightly to the prostate tissue to […]
Masimo wins FDA nod for NomoLine capnography sampling lines
Masimo (NSDQ:MASI) said today it won FDA clearance for its NomoLine capnography sampling lines. The newly cleared NomoLine sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors to allow for sidestream capnography and gas monitoring the Irvine, Calif.-based company said. The lines are designed for both intubated and non-intubated patients in low and high humidity […]
Repro-Med clears FDA warning letter, shuffles C-suite
Repro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite. Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance […]
Hologic wins FDA 510k for Quantra 2.2, inks dev & distro deal with Clarius
Hologic (NSDQ:HOLX) said recently that it won FDA 510(k) clearance for its Quantra 2.2 breast density assessment software and that it inked a development and distribution deal with Clarius Mobile Health for its wireless, handheld ultrasound scanner. The Marlborough, Mass.-based company said the Quantra 2.2 software uses a proprietary algorithm to analyze mammography images for the […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Get the […]
RxSight wins FDA nod for light-adjustable IOL
The FDA has cleared RxSight‘s implantable light adjustable intraocular lens and light delivery device. The company’s RxSight IOL is designed from a UV light reactive material meant to be treated by a specific Light Delivery Device, intended for use 17 to 21 days post-procedure. The lens is designed to be treated by 3-4 light treatments […]
Medicrea wins FDA nod for IB3D interbody devices
Medicrea (EPA:ALMED) said today it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology. The company’s AdapTEK technology is intended to allow surgeons to create interbody devices customized to individual specifications through in-house additive manufacturing techniques. Customization features include different ranges of footprints, lordotic angles, heights, lateral windows and […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in a statement, […]
Europe’s medtech alliance seeks prompt action on new med device rules
European medtech industry group MedTech Europe today said it is seeking “swift action” from national and European Union authorities after the implementation of new regulations, saying that additional resources need to be invested to make sure the regulations are successful. The medtech group published three separate position papers on the matter, calling attention to new […]
FDA clears remote adjustments for Cochlear’s Nucleus implants
The FDA last week approved remote programming adjustments for Cochlear Ltd.‘s (ASX:COH) Nucleus cochlear implant, removing the need for a select group of users to make repeat visits for in-person programming sessions. The newly-cleared remote programming feature is indicated for patients with 6 months of experience with their cochlear implant sound processors and who are […]