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.

The long-term use of ventricular assist devices is becoming a problem for at least some of these devices, as demonstrated by the recall of the Heartmate II and Heartmate 3 devices by Abbott Laboratories’ Abbott Vascular division due to obstruction of the outflow graft used to attach the device to the human heart.

Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.

In what represents its first patenting, Halifax, Nova Scotia-based Hollo Medical Inc. seeks protection for its product that is designed for inhaler users who are frustrated with cumbersome valved holding chambers and desire something more compact and portable.

In a departure from its focus on using implanted electrodes to treat urinary incontinence, Amber Therapeutics Ltd. has filed for protection of similar approaches to treat sexual dysfunction and pelvic pain.

Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.

Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.

The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.

Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.

Another med-tech acquisition was wiped off the charts after Japan’s Olympus Corp. rescinded the acquisition of South Korean medical device firm Taewoong Medical Co. Ltd. on March 7, after finding “data integrity issues” related to Taewoong’s products.