ABT unveils OTC glucose meter | Regulatory news for the week of April 20, 2015

April 21, 2015 By MassDevice

Abbott unveils over-the-counter glucose meter

April 17, 2015 by Val Kennedy

Abbott said it received FDA approval for a new, budget-priced glucose monitor that can be purchased without a prescription.

The over-the-counter FreeStyle Precision Neo meter will sell in the $22 to $28 range, with a package of 25 test strips costing between $14 and $17, the company said. Read more

Medtronic's Micra leadless pacemaker wins EU approval

April 14, 2015 by Brad Perriello

Medtronic’s entry into the leadless pacemaker market won CE Mark approval in the European Union, the company said today, touting it as the world’s smallest pacemaker.

The Micra transcatheter pacing system, which at ⅒ the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. Read more

FDA clears Conventus PH shoulder cage

April 17, 2015 by Mark Hollmer

Conventus Orthopaedics, with an FDA clearance in hand, plans a gradual rollout of a new device designed to help repair shoulder fractures in a less invasive way.

Conventus said it won 510(k) clearance from the FDA for its Conventus PH, a nitinol device that’s designed to expand inside the bone as an internal scaffold to prevent collapse of a shoulder fracture. Read more

FDA approves AcuFocus Kamra inlay

April 20, 2015 by Brad Perriello

The FDA last week approved the 1st implant designed to correct near vision loss in patients who have not had cataract surgery, the Kamra inlay made by AcuFocus.

The Kamra device, an ultra-thin, opaque ring that’s implanted under the corneal flap of the non-dominant eye in presbyopic patients, is designed to reduce the aperture of the eye and increase the depth of focus. Read more

Cardiac Assist wins CE Mark for emergency cannula

April 20, 2015 by Mark Hollmer

CardiacAssist last week said it nailed down CE Mark approval in the European Union for a cannula designed to both drain and re-infuse blood during life support procedures.

The Pittsburgh-based company said the Class 3 CE Mark covers its Protek Duo veno-venous cannula, a thin tube that’s inserted into a jugular vein to drain fluid and reinfuse blood during life support procedures for patients with acute respiratory distress syndrome. Read more

Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]
Goddard teams with Swab56 on COVID-19 test swabs
Mechanical engineering and industrial design company Goddard announced that it is working with the Swab56 Project to rapidly increase the production of Swab56’s test swabs, which are used in healthcare facilities to test for COVID-19. As news reports have documented, traditional nasopharyngeal swabs are in short supply as healthcare facilities around the world struggle to keep… […]
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases… […]
Sommetrics lands ISO 13485 certification
Sleep apnea treatment device startup Sommetrics announced yesterday that its quality management system has been certified to the ISO 13485:2016 standard. During the audit process required for certification, Sommetrics was also evaluated and found to be in compliance with the standards of the Medical Device Single Audit Program (MDSAP) for Canada. “This is an important… […]