Medical device recalls during the second quarter hit 360, the highest amount seen since 2005, according to a new Stericycle Expert Solutions report. Recalls were up 17, or 5% from the previous quarter, according to the report. Recalled units decreased 80% to approximately 42.4 million, lower than eight of the previous 13 quarters, according to […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
7D Surgical wins FDA nod for MvIGS nav system Cranial Module
Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system. The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms. The system’s navigation technology is embedded in an overhead surgical light […]
Endologix pushes Nellix release timeline to 2021
Endologix (NSDQ:ELGX) said it doesn’t expect to receive FDA premarket approval for its Nellix 3.5 endovascular sealing system until 2021. The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021. The forecast is […]
UK’s MHRA details what medtech should expect during Brexit
The UK’s Medicines and Healthcare products Regulatory Agency today released an update on what medtech and pharmaceutical companies can expect to see as the country begins to implement plans to split from the European Union. The Brexit agreement implementation period is set to end on December of 2020, according to the notice, during which the […]
Study slams FDA’s ‘fast-track’ approval process
More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows […]
FDA approves Ivantis’ Hydrus microstent
Ivantis said today it won FDA approval for its Hydrus microstent designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large […]
Adherium launches over-the-counter inhaler sensor in US
Adherium (ASK:ADR) today launched over-the-counter sales of its Hailie digital inhaler add-on in the U.S. The sensor is designed to integrate directly with prescription inhaler medications, sending adherence reminders and relevant data to a user’s smartphone to assist in managing chronic respiratory conditions like asthma and COPD. Get the full story at our sister site, Drug […]
SpaceLabs’ Arkon anesthesia system recalled again
The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use […]
GI Dynamics wins FDA nod for pivotal US EndoBarrier trial
GI Dynamics (ASX:GID) said today it won FDA investigational device exemption approval to launch a pivotal trial of its EndoBarrier device designed for treating patients with type 2 diabetes and obesity, pending Institutional Review Board approval. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
Inside Hologic’s evolving definition of women’s healthcare
Hologic (NSDQ:HOLX), known in the medtech industry for its mammography and diagnostics devices, is rethinking what it means to be a women’s healthcare company. The 6,000-person company wants to expand its reach to include products that care for women’s well-being, as well as their health – a concept that Dr. Edward Evantash honed when he led […]
J&J’s Cerenovus wins CE Mark for Bravo flow diverter
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said this week it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms. The newly cleared device is designed to divert blood flow from aneurysms to promote healing and reduce the risk of rupture, the company said. The Bravo is Cerenovus’ first flow […]