FDA Archives - Medical Design Sourcing

FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program

[Image from the SetPoint Medical website]SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot.

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week.

With acceptance into TAP, SetPoint can progress the development of its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS).

SetPoint designed its device to use precise vagus nerve stimulation. It activates anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.

The SetPoint platform features a miniaturized stimulation device placed on the vagus nerve. Onc…

J&J’s Abiomed has a Class I Impella recall with 49 deaths related to issue

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind.

Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.

This recall (a correction and not a product removal) affects a number of Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.

Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.

Abiomed recalled the left-sided blood pumps in this…

BD ups domestic syringe production in wake of FDA warnings on syringes made in China

BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China.

In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

Earlier this week, the agency issued warning letters to three companies, including U.S.-based Medline. The letters describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S.

In response to the latest developments, President of BD Medication Delivery Solutions, Eric Borin, issued a statement today.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears self-driving mobile C-arm from Siemens Healthineers

The Ciartic Move mobile C-arm with self-driving capabilities. [Image courtesy of Siemens Healthineers]Siemens Healthineers announced today that the FDA granted clearance for its Ciartic Move mobile C-arm with self-driving capabilities.

Ciartic Move accelerates and standardizes 2D fluoroscopic and 3D cone-beam computed technology (CT) imaging. Working in hospitals and outpatient facilities, it enables consistent automated workflows and reduced imaging time.

Siemens Healthineers designed the system to address the needs of orthopedic, trauma and spine surgery. However, it also has utility in thoracic, vascular, cardiovascular and general surgery, plus urology and interventional pulmonology.

According to a news release, Ciartic Move could address intraoperative imaging challenges caused by staff shortages and overloaded OR teams. A fully motorized C-arm can reduce the time, effort and workforce capacity needed to manually move and position the system. It has up…

FDA issues warning letter to Medline over plastic syringes from China

The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline.

In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

On March 18, 2024, the FDA issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to three companies: Jiangsu Shenli Medical Production, Medline Industries and Sol-Millenium Medical.

Medline — the fourth-largest medical device company in the world, according to our 2023 Big 100 list — markets and distributes plastic syringes made in China within the U.S.

Get the…

Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today.

Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system.

“We are planning for a limited launch starting in the U.S. as we optimize manufacturing and supply chains, and progressively expand our manufacturing capacity,” CFO Jamie Samath said. “We expect to be in this limited launch phase into 2025. During this period, we will be focused on customers that collaborated with us during the development period and those customers who have mature robotic programs and have a need to expand capacity.”

Others who…

Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold

The Freesolve scaffold. [Image courtesy of Biotronik]Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold.

The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.

Lake Oswego, Oregon-based Biotronik based its system on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Previous data demonstrated 99.6% degradation of magnesium 12 months after implantation into coronary arteries.

In BTK interventions, Biotronik says the Freesolve’s characteristics can offer particular value. In these situations, vessel scaffolding in the short-term resists vessel reco…

Intuitive wins FDA clearance for its next-gen da Vinci 5

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + announced today that it secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system.

The news comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here is our roundup of top surgical robotics companies.)

The da Vinci 5 joins Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5…

EPA starts the clock on new EtO sterilization emissions rule

Commercial sterilization facilities will have two to three years to comply with a new ethylene oxide (also referred to as EtO or EO) sterilization emission rule announced by the EPA today.

However, the EPA said it will not require commercial sterilizers to use lower concentrations of EtO or to limit the use of packaging and pallet material, citing industry feedback.

Addressing the potential for medical device shortages if sterilizers are unable or unwilling to comply, the agency’s final rule also includes presidential authority for two-year exemptions for stationary sterilizers if the commander-in-chief “determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so.”

The EPA’s previous proposal would have only allowed 18 months for compliance.

The EPA said the new EtO sterilization limits and air pollution control requirements will …

SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis

[Image from the SetPoint Medical website]SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.

Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval.

This isn’t the first breakthrough nod for SetPoint’s technology. It picked up the designation in 2020 to treat rheumatoid arthritis (RA). The company continues evaluating the investigational platform in a pivotal clinical trial for the treatment of RA.

However, the latest breakthrough nod helps the company explore the technology for yet another condition. SetPoint’s platform features a miniaturized stimulation device placed on the vagus nerve. Once placed through a small inc…

Recall of Abbott HeartMate comms system is Class I

The HeartMate 3 LVAD. [Image courtesy of Abbott]The FDA deemed a recall of the Abbott (NYSE: ABT) + HeartMate Touch Communication System Class I, the most serious kind of recall.

Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero deaths related to this recall.

In total, the recall affects 1,560 devices in the U.S. distributed between May 7, 2020, and Dec. 18, 2023. Abbott initiated the recall on Jan. 3, 2024.

The HeartMate Touch Communication system monitors patients who have an implantable HeartMate 3 left ventricular assist device (LVAD). Abbott has previously reported that HeartMate 3 can extend the lives of advanced heart failure patients by at least five years.

HeartMate’s communications system works with a controller and includes a tablet…

FDA accepts Onward BCI into advisory program

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology.

Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a requirement for TAP consideration, according to a news release. Onward says that this nod made its BCI only the second such system accepted into the program.

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Onward can benefit from more timely premarket interactions, earlier identification and mitigation of device development risk and a more efficient premarket review for its ARC-BCI system.

ARC-BCI uses brain-computer i…