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Home » Topics » Regulatory

Regulatory
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Medtronic - Affera Mapping and Ablation System

FDA OKs study of Medtronic’s Affera in ventricular tachycardia

Oct. 17, 2024
By Annette Boyle
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
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U.S. Capitol building, Washington D.C.

Advamed hopeful House breakthrough device bill will pass in ‘24

Oct. 17, 2024
By Mark McCarty
The med-tech industry has been keen to see government fill in the so-called valley of death for breakthrough medical devices for some years, and 2024 may be the year it is finally done. Scott Whitaker, president and CEO of the Advanced Medical Technology Association said in an Oct. 16 press briefing that a House bill may pass during the upcoming lame duck session, bringing to a close an effort that has been the better part of a decade in the making.
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FDA pauses Novavax’s flu and COVID-19 combo vaccines

Oct. 16, 2024
By Jennifer Boggs
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
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FDA sign

US FDA Rare Disease Hub an answer to regulatory challenges?

Oct. 16, 2024
By Mari Serebrov
Coming on the heels of an advisory committee in which the U.S. FDA and its independent advisers grappled with trying to fit an ultra-rare disease development program into the confines of the agency’s “significant evidence” requirements, an Oct. 16 public meeting on a Rare Disease Innovation Hub the agency is setting up seemed like a welcome step in the right direction for rare disease patients, their caregivers and companies working in the space.
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Novocure's Optune Lua

Novocure’s tumor treating fields land FDA approval for lung cancer

Oct. 16, 2024
By Annette Boyle
Novocure GmbH secured U.S. FDA approval for Optune Lua, a wearable device that delivers alternating electric fields or tumor treating fields that kill cancer cells. Indicated for use with PD-1/PD-L1 inhibitors or docetaxel in the second or subsequent line for the treatment of metastatic non-small-cell lung cancer following the failure of platinum-based regimens, the approval was driven by the significant improvement in overall survival rates seen in the LUNAR pivotal study for Optune Lua.
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AI biotech research concept with lightbulb and digital background
2024 Med Tech Conference

CBO scoring impedes expanded Medicare digital benefit categories

Oct. 16, 2024
By Mark McCarty
The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.
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EU flags
2024 Med Tech Conference

EU's MDR pain points exacerbated by lack of member state harmony

Oct. 16, 2024
By Mark McCarty
The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.
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Anovos miniature flexible robotic arms

FDA clears Momentis, CMR robotic systems

Oct. 16, 2024
By Shani Alexander
The U.S. FDA granted Momentis Surgical Ltd. 510(k) clearance for its Anovo robotic surgical platform for use in single site, abdominal access ventral hernia repairs. The U.S. regulatory agency also gave the greenlight to CMR Surgical Ltd.’s Versius system for use in cholecystectomy, in a sign of the growing market for smaller, more portable robotic devices to assist in minimally invasive procedures.
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Illustration of pancreas, close up of islet
Endocrine/metabolic

Seraxis gains IND clearance for islet replacement therapy

Oct. 16, 2024
Seraxis Inc. has obtained IND clearance from the FDA for a phase I/II study of its novel islet replacement therapy SR-02 for type 1 diabetes. SR-02 is comprised of allogeneic pancreatic endocrine cell clusters that, when implanted to the omentum, form a functional endocrine pancreas outside of the native pancreas.
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BioWorld Insider podcast: Gene and cell therapies will propel innovation

Oct. 15, 2024
By Lee Landenberger
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
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