CDRH Pilots Recall Communications Initiative
The public may soon get earlier notice of high-risk recalls for several device sectors under a new pilot program from the Center for Devices and Radiological Health at the US Food and Drug Administration.
The program, which was announced on 21 November, will include product removals, product corrections, and updates to instructions for use for cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices. No changes are being made at this time to recall procedures for other product areas.
According to the FDA, the pilot was inspired by suggestions made during an October 2021 meeting of the Patient Engagement Advisory Committee, as well as ongoing agency efforts to improve device safety and recall communications.
“Today, I reaffirm our commitment to proactively addressing safety concerns, managing recalls effectively, and building on the foundation laid by my predecessor, Dr. Jeff Shuren, whose initiatives paved the way for the development of systems that enhance our detection, monitoring, and remediation of device safety issues and advance patient safety,” said CDRH head Michelle Tarver.
Cardinal Pays $3.9B In Twin Acquisition Of Diabetes And GI Players
Cardinal Health has agreed to pay $1.1bn to buy the US-based Advanced Diabetes Supply Group (ADSG). It has also announced plans to acquire at least 71%, and potentially up to 100%, of GIA Alliance, the leading US gastroenterology management services organization, for $2.8bn.
The transactions, both announced on 11 November, will augment the Dublin, Ohio company’s at-home solutions and “multi-growth” strategies, respectively.
ADSG’s direct-to-patient diabetes business will slot into Cardinal’s “Other” division, which houses the company’s nuclear, precision health and at-home solutions. The acquisition of the firm, which offers diabetes therapies to half a million patients annually, fits Cardinal’s newly identified priority of investing in growth businesses and playing a greater role in “where the future of healthcare is going,” said Cardinal’s CEO, Jason Hollar.
The GIA stake, which was purchased chiefly from physician owners, will serve as a platform within Cardinal’s $210bn pharma and specialty solutions segment. Cardinal says this acquisition will add significant depth to its anesthesiology, pathology, infusion, radiology and clinical research offerings across US ambulatory surgical centers, hospital networks and infusion centers.
Neither acquisition immediately impacts revenues of the $12.4bn global medical products and distribution (GMPD) segment. This grew by a nominal 1% in 2023-24. GMPD has recently undergone a strategic improvement plan, overseen by Hollar.
Combined, GMPD and “Other” revenues keep Cardinal Health within the top ten global medtechs in Medtech Insight’s Global Top 100 ranking of publicly listed companies for 2023/2023-24, due to be published on Medtech Insight’s website in December.
Foundation Medicine Liquid Biopsy Test FDA-Cleared As Tepmetko CDx
Liquid biopsy company Foundation Medicine announced on 18 November that the US Food and Drug Administration has cleared its FoundationOne Liquid CDx blood test as a companion diagnostic for Tepmetko, a drug used to treat adults with metastatic non-small cell lung cancer (NSCLC).
The company said that this marks the first FDA-approved companion diagnostic to identify patients who may be eligible for the drug, which is made by Germany-based Merck KGaA.
Tepmetko is used in patients who have a genetic mutation known as METex14 skipping, which has been associated with poor prognosis. About 3-4% of NSCLC patients are eligible, the company said.
Medtronic Receives FDA Clearance For New InPen App
Medtronic announced on 20 November it received FDA clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI (multiple daily injection) therapy with the Simplera continuous glucose monitoring system.
The system will be first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals with MDI therapy, the company said.
For people with diabetes who need multiple daily injections, bolusing before a meal is key to regulate glucose levels and prevent blood sugar spikes after eating. But because these patients regularly miss doses, Smart MDI’s “missed dose alert function” helps to taking the guesswork out of diabetes management.
The app will be available on a limited basis for existing GCM and InPen clients before its full launch.
GI Windows Surgical Raises $37M In Series B To Advance Magnetic Anastomosis
GI Windows announced on 20 November it secured $37m in additional funding to support the continued clinical development and commercialization of its Self-Forming Magnet, Flexagon and delivery systems.
The financing round was led by Orlando Health Ventures and joined by Rex Health Ventures with participation from existing investors including Johnson & Johnson Innovation-JJDC, JCInvestco, Fred Moll and an additional strategic investor, the company said.
The company’s self-forming magnets can be delivered by endoscope to internal surgical sites as an alternative to surgical staples. A 2023 study that compared early healing of end-to-end small bowel anastomosis by self-forming magnets with surgical stapling in pigs showed that the self-forming magnets were associated with “superior early histologic healing metrics, including early seal generation through mechanical compression, decreased inflammation, early neovascularization, lower bacterial infiltration and faster re-epithelization,” according to study results published in the medical journal Surgery.
CAP Letter Urges Trump Administration To Rescind FDA’s LDT Regulation
The College of American Pathologists (CAP) is asking the incoming Trump Administration to rescind the FDA’s proposed regulation of laboratory developed tests (LDTs), raising several concerns.
“We are concerned about the final version of the FDA rule for several reasons,” CAP president Donald S. Karcher wrote in a 19 November letter to Trump transition team co-heads Linda McMahon and Howard Lutnick. “Most importantly – because of its impact on patient access to critically important diagnostic tests.”
Furthermore, Karcher concerns about the “timeline of the implementation and the unsustainable costs that will hinder the development of LDTs.”
“Pathologists and laboratories fear these regulatory restrictions from the FDA will make it difficult for laboratories to continue to develop and provide LDTs, and thus, impair and delay the diagnosis of disease and treatment of patients,” the president wrote.
Clinical labs and diagnostics firms are grappling with the likely impacts of the FDA’s final rule on LDTs with a key concern being the potential business effects of the increased regulatory burden.
Advance Tests Launches Multi-Marker Alzheimer’s Diagnostic In UK
Advance Tests, a commercial brand of Quanterix Corporation, announced the UK launch of a multi-marker non-invasive Alzheimer’s diagnostic, LucentAD Complete, on 18 November.
“We’re proud to exclusively bring LucentAD Complete to the UK, offering healthcare providers and patients a reliable and accessible diagnostic aid that can transform Alzheimer’s care,” said Simon Worrell, founder and chief medical officer of Advance Tests.
LucentAD Complete detects several Alzheimer’s biomarkers, such as plasma phosphorylated tau at threonine 217(p-Tau 217), Beta amyloid (Aβ42/40), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL).
The test will be available at Advance Tests’ London clinic as of 2 December.
WOUND-Q Wins MDDT Qualification
The FDA has qualified the WOUND-Q instrument through its Medical Device Development Tools (MDDT) program, the agency recently announced.
The MDDT program provides a pathway for the FDA to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices. Using this program, the agency has qualified tools to help with the development of a wide range of device types, such as cardiovascular, neurology, ophthalmology, plastic surgery, automated insulin dosing, and imaging devices, as well as crosscutting tools for implanted medical devices and cybersecurity.
WOUND-Q is a new patient-reported outcome instrument to measure outcomes in individuals with nonhealing chronic wounds. It features a set of seven patient-reported outcome measures, or PROMs, that evaluate wound characteristics, such as assessment, drainage, and smell — and impacts on health-related quality of life, such as on sleep and social life.
The scores are tallied, ranging from 0 to 100 using a respective scoring table for each scale. Higher scores indicate better outcomes.
QOL Medical Pays $47M In Kickback Settlement
Florida-based drug firm QOL Medical has agreed to pay $47M to resolve allegations the company offered free breath tests to induce use of its drug Sucraid, the US Department of Justice announced on 15 November.
Sucraid is used to treat a rare genetic condition, Congenital Sucrase-Isomaltase Deficiency (CSID), which causes difficulty digesting table sugar. People with CSID will show low sucrase activity on a Carbon-13 breath test; however, the breath test alone is not enough to diagnose CSID because other conditions can cause low sucrase activity.
According to the DOJ, QOL gave free Carbon-13 breath test kits to health care providers and asked providers to give the kits to patients complaining of diarrhea, nausea, and other common digestive complaints. The company told providers that the tests could “rule in or rule out” CSID, which was not true. In one training session, the company suggested sales reps tell providers that “If you have a positive breath test, the patient will not improve unless you treat with Sucraid.”
QOL and CEO Frederick Cooper admitted responsibility as part of the settlement.
“QOL provided free goods to doctors and patients in order to induce prescriptions for the very expensive drug QOL manufactured,” said Joshua Levy, acting US Attorney for the District of Massachusetts. “Not all kickbacks come in the form of cash going into a doctor’s or a patient’s pocket. Here, the defendants relied on free breath tests and misleading sales tactics to drive patients to their product. This conduct unnecessarily drained money from the federal health care programs and improperly influenced treatment decisions by physicians and their patients.”
New FDA Guidance Documents On Non-Spinal Bone Fasteners
The FDA issued two new guidance documents on non-spinal bone plates, screws, and washers on 21 November. One guidance document offers agency suggestions for 510(k) submissions for these device types, while the other explains how developers of the orthopedic fasteners can use the Safety & Performance Pathway to get FDA clearance without a direct comparison to a predicate device.
The Safety & Performance Pathway allows sponsors of certain well-understood device types to earn a 510(k) clearance by demonstrating that they meet certain criteria, eliminating the need for substantial equivalence to a device already on the market. In the case of the bone plates, screws, and washers, these criteria include both mechanical and biochemical testing.
