News We’re Watching: FDA Warning Letters; First Hysterectomy With MIRA Robot; DOJ Finalizes Rule On Accessibility; And More

FDA Warns Manufacturer Of Defibrillator Batteries For PMA Failure

In a recent warning letter to AMCO International Manufacturing & Design, Inc., a manufacturer of batteries for automated external defibrillators, AEDs, the US Food and Drug Administration said the firm failed to file a premarket approval within the necessary timeframe.

The letter stems from a March inspection of the firm.

As noted in the letter, the agency issued a final order in 2015 requiring manufacturers of AED accessories, such as batteries, to submit a PMA within 90 days.

AMCO makes batteries for AED systems for various manufacturers, including Cardiac Science Powerheart, Philips Healthcare, OnSite, Home, and Physio-Control LifePak.

In its letter, the FDA informed AMCO that it not only failed to meet the deadline but “continued to manufacture and distribute these devices after the compliance date.”

The agency further warned the company to “cease activities that result in the adulteration of necessary AED accessories” and quickly correct the violations addressed in the letter.

UCSD Study Finds Truvian Point-Of-Care Blood Testing Platform Performs Well Against Lab Testing

Researchers from UC San Diego School of Medicine provided further evidence that Truvian Health’s point-of-care blood testing platform performed well in comparison to FDA-cleared devices found in central laboratories.

The study enrolled 50 unique donors representing various states and collected three 4-mL blood samples from each donor – one Lithium Herparin sample from the Truvian System’s TruWellnessPanel, a LiHep gel tube for Roche Cobas clinical chemistry and TSH assays and an EDTA sample for the Sysmex complete blood count with 3-part differential and HbA1c, according to the poster presented on 30 July at the Association of Diagnostics and Laboratory Medicine meeting in Chicago. Findings showed that Truvian’s instrument met pre-specified reliability, precision and accuracy criteria with reproducibility of results being 100%.

“The present evaluation underscores Truvian’s instrument as an easy-to-operate platform that can be run by untrained operators, maintain reliability in real-world clinical settings, and deliver accurate and precise results,” wrote study author A. B. Wells et al. 

Truvian announced in July it raised $74m in venture capital funding led by Wittington Ventures and Great Point Ventures with support from existing investors. The company plans to use the proceeds to secure FDA clearance for the blood testing platform, which can generate 34 test results including lipid, TSH and CBC in under 30 minutes. (Also see "Truvian Health Raises $74M In Funding For Automated Benchtop Blood Testing Analyzer, Pursues FDA Clearance" - Medtech Insight, 18 Jul, 2024.)

Virtual Incision Completes First Hysterectomy Using Miniaturized MIRA Robotic Surgery System

Virtual Incision Corp. successfully completed the first hysterectomy with the company’s miniaturized robotic-assisted surgery device, the MIRA Surgical System, at Geneva University Hospitals.

The international prospective clinical study was initiated in February following the FDA de novo authorization of MIRA for colectomy procedures in adults. It is the second clinical study following the first US Investigational Device Exemption protocol supporting the de novo authorization.

In the new study, Virtual Incision plans to assess the safety and performance of the MIRA Surgical System when used to robotically assist in benign hysterectomy procedures. The company intends to use the study's outcomes to support the US and international regulation submission for benign gynecologic indications, the company said.

“Robotic-assisted surgery is a valuable tool, but technology access is still challenging due to cost, time, and operating room space. Miniaturization has the potential to overcome these issues and enable more women to have a minimally invasive option for their surgery,” said the surgeon who completed the first hysterectomy surgery with MIRA, Jean Dubuisson, gynecologic surgeon and principal investigator for the MIRA Surgical System hysterectomy study.

“We are pleased with the results so far and look forward to further assessing the device in the MIRA Hysterectomy Study,” said the surgeon who completed the first surgery,” she said

MIRA is the world’s first miniaturized robotic-assisted surgery system. The device weighs approximately two pounds and “offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body,” said the company.

DOJ Finalizes Rule On Accessible Medical Equipment

The US Department of Justice has finalized a rule that requires government-operated health care facilities to provide accessible versions of equipment such as scales, dental chairs, examination tables and X-ray machines for people with disabilities. (Also see "DOJ Proposed Rule Would Improve Access To Diagnostic Equipment For People With Disabilities" - Medtech Insight, 11 Jan, 2024.)

Attorney General Merrick Garland signed the rule, which is being implemented under the Americans with Disabilities Act, on the ADA’s 34th anniversary on 26 July. It will be published in the Federal Register in the coming days.

The DOJ explained that it implemented the rule after learning that many Americans forego needed medical care because they cannot use the equipment that is available to them. For example, people in wheelchairs sometimes were not given full medical exams because they could not be transferred to the facility’s exam table.

“This rule marks a significant milestone in our ongoing efforts to ensure that people with disabilities can get the medical treatment they need,” Assistant Attorney General Kristen Clarke of the Civil Rights Division said in a statement. “Whether you are talking about access to mammograms or access to general OB/GYN services, it is critical that hospitals and doctors’ offices provide equipment that is accessible to patients with disabilities.” 

FDA Compiles Resources On Device Reprocessing

The FDA has compiled its resources on reprocessed medical devices onto a new web page, the agency announced this week. The agency explained that the guide is intended “to help health care facilities establish, implement, or improve their quality assurance programs related to reprocessing single-use medical devices.”

The page includes overviews of relevant statutory and legal requirements for class I, II and III devices, as well as information on labeling and postmarket requirements and links to additional resources.

Ensuring the safety of device reprocessing has been a focus of the FDA in recent years, since the use of reprocessed endoscopes was linked to the spread of antibiotic-resistant “superbugs.” Endoscope manufacturer Olympus has received multiple warning letters related to issues with the company’s quality management systems that could harm patient safety. (Also see "FDA Slaps Olympus With Another Endoscope Warning" - Medtech Insight, 4 Apr, 2023.)

PreciseDx Economic Impact Study

PreciseDx, an oncology diagnostics firm, announced results of an economic impact study based on a hypothetical cohort of one million US women with early-stage invasive breast cancer that compared costs of treatment guided by standard of care risk assessment versus using its test to predict six-year risk of recurrence in early-stage invasive breast cancer.

According to the study, the use of PreciseDx as part of evaluating a recurrence risk evaluation in the hypothetical cohort achieved $4m in cost savings in the first year compared to current standard of care and rose to $12.5m over six-years, the New York-based company said in its report published in the July issue of the Journal of Medical Economics. The per treated patient costs in year one amounted to $19,500 for standard of care versus $16,900 for PreciseDx Breast, an AI-augmented histopathology platform that assesses six-year risk of recurrence in early-stage invasive breast cancer patient to help improve informed use of adjuvant chemotherapy. MT145320

“The use of PreciseDx Breast to assess breast cancer recurrence risk has the potential to fill gaps in care and reduce costs when gene expression signatures are not available,” wrote study author Salwa Masud.