AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.
While the road ahead might be unpredictable, the core dynamics of the life sciences sector and the coming expiry of patents worth over $100 billion are poised to drive a renaissance in biotech mergers and acquisitions.
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
The Get Well platform is used at more than 70 Veteran Affairs Medical Centers (VAMCs). Now that it is listed on the FedRAMP Marketplace, the Get Well digital patient engagement platform can be contracted by any government agency without additional security vetting required.
As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.
The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. The workshop is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET.
Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.
The MedTech industry has grown too comfortable with “essential use” exemptions and is ignoring the growing liability, supply chain and regulatory risk of PFAS use in medical devices and manufacturing facilities.