Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term.
The U.S. FDA said the results of a Section 522 postmarket surveillance study of transvaginal mesh devices by Boston Scientific Corp. suggested similar effectiveness and safety outcomes at 36 months compared to native tissue repair. However, the agency said patients with mesh repair for pelvic organ prolapse (POP) are exposed to additional risks, such as mesh exposure and erosion, and thus the agency is disinclined to allow these devices back onto the market.
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.
A change of presidential administrations often brings a significant change in regulatory policy, and the Granston memo did just that shortly after the Trump administration took office in 2017. However, the Department of Justice (DoJ) has dismissed fewer whistleblower (qui tam) lawsuits against the private sector recently, a trend that Jonathan Phillips of Gibson Dunn said was evident before the Biden administration took over.
Medcura Inc. has secured $7.4 million in series A equity financing to grow its line of hemostatic and wound treatment products. Part of the proceeds from the investment will go toward further developing the company’s lead surgical candidate, Lifegel, and advancing it to clinical trials.
The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population.
The U.S. Federal Trade Commission (FTC) has made no secret of its intent to tighten its oversight of merger and acquisition (M&A) activity, an emphasis that has already been felt in the med-tech space. Soliton Inc., of Houston, said in its latest 8-K filing that the FTC wants to see more information about plans for the company to be acquired by Allergan Aesthetics plc, a demand that at the very least will delay – and potentially derail altogether – the acquisition.
The frequent calls for an expansion of telemedicine have come with relatively hushed advisories about the potential for fraud, concerns that have been borne out by an indictment recently returned by a federal grand jury in New Jersey. A company that presented itself as a provider of telemedicine services has been charged with filing $784 million in false claims for unnecessary durable medical equipment.
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