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2023 Med Tech Conference

FDA’s Shuren says agency decidedly moving away from up-or-down vote at advisory hearings

Oct. 12, 2023
By Mark McCarty

The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.


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Opsens Savvywire

Haemonetics doesn’t skip a beat with $253M Opsens deal

Oct. 11, 2023
By Annette Boyle
Haemonetics Corp. returned to the M&A trail with an agreement to buy Opsens Inc., a cardiology-focused medical device company, for CA$2.90 (US$2.13) per share for a total of CA$345 million (US$253 million). The all-cash transaction, its third significant purchase in five years, is expected to close by late January 2024, pending the approval of regulators and 66.66% of voting shareholders. Haemonetics expects the deal to be immediately accretive to adjusted earnings per share (EPS).
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Airamed Airascore

Airamed’s AI brain software a ‘game-changer’ for early Alzheimer's diagnosis

Oct. 11, 2023
By Shani Alexander
The U.S. FDA 510(k) clearance of Airamed GmbH’s Airascore software could see millions of people benefitting from early accurate diagnosis of Alzheimer’s disease and other types of dementia. Airascore is a medical image management and processing system that uses deep learning and artificial intelligence (AI) to assess brain volumetry data on MRI scans in as little as five minutes.
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U.S. FDA headquarters

Abiomed stung by FDA’s final guidance for clinical decision support in warning letter

Oct. 11, 2023
By Mark McCarty
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance and start over, but that doesn’t mean the agency is not enforcing the terms of the guidance. Danvers, Mass.-based Abiomed Inc., took in a Sept. 19 warning letter stating that the company’s Impella Connect system qualifies as a CDS product because it provides “patient-specific medical information to detect a life-threatening condition,” an interpretation that is sure to intensify the larger debate about whether the CDS final guidance is an extra-statutory exercise in regulatory engineering.
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Laptop displaying FDA logo
2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.


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Inbrain graphene-based cortical brain interface

Inbrain granted breakthrough device designation for graphene-based neural platform

Oct. 9, 2023
By Shani Alexander

Inbrain Neuroelectronics SL was granted a breakthrough device designation from the U.S. FDA for its graphene-based neural platform as an adjunctive therapy for treating Parkinson’s disease. The platform, called intelligent network modulation system, harnesses the power of graphene and artificial intelligence to deliver highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks, easing the symptoms of Parkinson’s.


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