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Black and white arrows merging into one
MDMA Annual Meeting

Compliance concerns driving more due diligence in med-tech M&As

April 19, 2024
By Mark McCarty
Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction.
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Cancer tumor in breast illustration

Lumicell shines a light on residual breast cancer with FDA approvals

April 19, 2024
By Annette Boyle
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.
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British flag

UK taking steps to boost adoption of med tech at the NHS

April 19, 2024
By Shani Alexander
The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives.
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Transmission electron microscopic image of hepatitis B virus.
Infection

YS Biopharma’s HBV immunotherapeutic vaccine YS-HBV-002 cleared for clinic

April 19, 2024
YS Biopharma Co. Ltd. has received clinical trial approval by the Philippine Food and Drug Administration to begin a phase I trial of its YS-HBV-002 immunotherapeutic vaccine, designed to treat chronic hepatitis B virus (HBV) infection. The trial will begin in the Philippines in June.
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China clears Immuneonco’s CD47 inhibitor for pivotal trials

April 18, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors.
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Gavel and FTC logo

Member of US House blasts FTC/DOJ merger guidelines

April 18, 2024
By Mark McCarty
The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in.
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Laptop displaying FDA logo
MDMA Annual Meeting

FDA’s Shuren calls for an end to the debate over LDT accuracy

April 18, 2024
By Mark McCarty
While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate.
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Artificial intelligence and digital health icons
MDMA Annual Meeting

Cassidy sees risk of hurried US legislation for AI

April 18, 2024
By Mark McCarty
One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves.
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Bone marrow illustration with doctor background

Scopio wins FDA clearance for bone marrow aspirate application

April 18, 2024
By Shani Alexander
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.
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Acute myeloid leukemia
Immuno-oncology

Bivictrix’s BVX-001 awarded US orphan drug designation for AML

April 18, 2024

Bivictrix Therapeutics plc’s BVX-001 has been awarded orphan drug designation by the FDA for acute myeloid leukemia (AML).


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