Articles Tagged with ''conference''

EU flags at European Commission building

LSI Europe

Opportunities remain in the EU for med tech despite US shift

Sep. 11, 2025

Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.

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.

Boston Scientific Corp.’s Watchman Flx device

TCT 2023

With Amulet or Watchman, 50% of patients still leak either way

Oct. 26, 2023

By Annette Boyle

Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure.

TCT 2023

Anteris provides update on biomimetic valve for aortic stenosis

Oct. 25, 2023

By Annette Boyle

Anteris Technologies Ltd. presented multiple sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 annual meeting in San Francisco this week on its novel Duravr biomimetic heart valve, a balloon-expandable, single-piece transcatheter aortic valve designed to closely replicate the shape and performance of a human aortic valve. The device was used for the first time earlier this year in a valve-in-valve replacement procedure and began its early feasibility study, both of which were reviewed at the cardiology meeting.

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.

2023 Med Tech Conference

Congress seen as having leeway to bring LDT user fees on board midstream in MDUFA VI

Oct. 9, 2023

By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.

Map of Australia with pills, vials and syringe

Ausmedtech 2023: Should Australian med techs bother commercializing products at home?

May 24, 2023

By Tamra Sami

With venture capital quite scarce, Australian med techs often question whether it makes sense to try to commercialize their products in their home market or whether they should partner to go offshore, but there are other options, said presenters at the Ausmedtech 2023 conference in Adelaide May 24.

Heart Rhythm 2023

Ebr’s WiSE device promises solution to left bundle branch pacing dilemma

May 23, 2023

By Mark McCarty

Bringing both ventricles back into synchrony has long been the subject of cardiological hopes in patients with heart failure, but current approaches to maximizing the function of the left ventricle leave many patients in a desperate state of cardiac dyssynchrony. However, Ebr Systems Inc., has reported the results of a study that demonstrates that its WiSE device can pace the left ventricle in patients who are unresponsive to conventional pacing in an effort to restore optimal left ventricular function, a development Sunnyvale, Calif.-based Ebr says will allow the company to conclude a premarket filing with the U.S. FDA.

R-One+-work-station-and-robotic-unit.jpg

EuroPCR 2023

Robocath launches Robotic platform for cardiology as Siemens drops business

May 22, 2023

By Shani Alexander

Robocath SAS is about to embark on a limited market release of its robotic platform, the R-One+, which will not only make performing coronary angioplasties easier and safer but will protect cardiologists from radiation, CEO Lucien Goffart told BioWorld in an interview. However, the launch comes on the heels of a decision by Siemens Healthineers Inc. to discontinue its robotic-assisted endovascular cardiology business as it did not meet the company’s “initial expectations.”

Clinical research concept with medical icons on light bulb

Heart Rhythm 2023

Pulsed field ablation gains yet more traction in new studies

May 22, 2023

By Mark McCarty

Pulsed field ablation (PFA) seems to have seized the moment in the field of cardiac electrophysiology, given its seemingly superior performance over other ablation modalities as a treatment for atrial fibrillation (AF). New data from three studies were presented at this year’s annual meeting of the Heart Rhythm Society that further confirm the value of PFA as a treatment for both persistent and paroxysmal AF with data sets that seem to confirm that PFA is poised to sweep aside the current standards for ablation, potentially overturning a treatment paradigm that took decades to establish.