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What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers top the Big 100 list of largest medical device companies by revenue.

The 2022 edition of MassDevice and Medical Design & Outsourcing‘s Big 100 report also holds surprises. Big conglomerates are spinning out medtech businesses as stand-alone companies, and that means changes to the list of 100 largest medical device companies.

Colfax, for example, engaged in business moves that turned DJO’s parent into Enovis, a large, stand-alone orthopedic device company that is No. 56 in 2022’s Big 100. ZimVie, formerly Zimmer Biomet’s spine and dental business, is 69th. And after decades under larger corporate umbrellas, Cordis debuts at No. 76 on the list.

We collected thousands of data points to size up the industry’s publicly traded companies and privately held firms. The Big 100 includes annual revenue, R&D spending, employee counts, key leaders, headquarters locatio…

Data supports Abbott Amplatzer Piccolo for fixing holes in newborn hearts without surgery

[Image from Abbott]Abbott (NYSE:ABT) announced today that three-year data demonstrated the positive impact of its Amplatzer Piccolo Occluder on babies.

The device treats newborns — some weighing as little as two pounds — with a hole in the heart. The condition, known as patent ductus arteriosus (PDA), is potentially life-threatening. PDA is present in approximately one of 2,000 births, per the Journal of Interventional Cardiology.

Abbott Park, Illinois-based Abbott’s study found low adverse rates following a piccolo procedure. The company said in a news release that it shows the additional benefit of the device that can help babies avoid riskier surgery. Before the introduction of the device, a decision often had to be made between putting a baby on respiratory support to see if the defect sealed on its own or conducting the risky surgical procedure to close the PDA.

The Amplatzer Piccolo is smaller than a pea, the company said. Abbott said it represe…

FDA clears next-generation RhinAer stylus from Aerin Medical

[Image from Aerin Medical]Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus.

Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session.

The new RhinAer provides physicians with improved visualization, easier access and tissue apposition. Aerin said in a news release that this is especially helpful in patients with narrow nasal airways.

“The new RhinAer stylus gives me confidence that I can access and treat the posterior nasal nerve area more effectively,” said Dr. Randall Ow, otolaryngologist at Sutter Health in Sacramento and the first physician in the world to use the device on a patient. “This newer generation RhinAer allows me to confidently treat multiple target areas, in the office setting, e…

Axonics announces first patient implants in Canada for sacral neuromod system

Axonics (Nasdaq:AXNX) today announced the first patient implants in Canada for its Axonics F15 sacral neuromodulation (SNM) system.

Irvine, California-based Axonics designed its new F15 as a long-lived, fully recharge-free SNM system. It received Health Canada approval after FDA approval in March. The company’s U.S. launch took place the following month.

According to a news release, the University of Alberta implanted four patients with F15 this week. The patients were programmed at stimulation amplitudes between 0.95mA and 0.30mA. The resulting expected battery longevity ranges from 18 years to more than 22 years.

“The approval of the Axonics recharge-free system is welcome news for patients in Canada suffering from bladder and bowel dysfunction,” said Dr Gary J. Gray, a urologist and clinical professor at the Kipnes Urology Centre in the Department of Surgery at the University of Alberta. “I am excited to now offer patients a recharge-free option…

Analysts see multi-year transition to growth for Embecta

Embecta (Nasdaq:EMBC), the BD diabetes business spinoff, may take a few years to move into a growth phase, analysts say.

BTIG analysts Marie Thibault and Sam Eiber wrote a report labeling Embecta as a “Neutral” option on the market. BD initially announced it would spin off its diabetes business in 2021, finally completing the move in April 2022.

The company’s first quarterly results as a spinoff inspired early confidence, beating the consensus forecast on Wall Street. However, the analysts aren’t jumping at the stock too soon.

“We expect this to be a multi-year transition from a value story to a growth play,” Thibault and Eiber wrote.

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

Otolith labs raises $20M for wearable device that treats vertigo

[Image from Otolith Labs’ website]Otolith Labs announced today that it closed a $20 million Series A financing round by Morningside Ventures.

Washington, D.C.-based Otolith plans to use the proceeds to support its ongoing clinical programs, regulatory approvals and commercial launches. The funds build upon previous investments from entrepreneur Mark Cuban and ENT physicians.

The company develops a prescription wearable device for the treatment of chronic vertigo. It uses noninvasive vestibular system masking (nVSM) technology. The device picked up FDA breakthrough device designation last year.

Otolith Labs designed its nVSM technology to provide immediate symptom relief. It applies localized mechanical stimulation to the vestibular system through calibrated vibrations.

The company plans to begin enrolling patients in a pivotal study “soon,” according to a news release.

“The closing of our Series A financing led by the expert …

Centinel Spine announces first commercial use of total disc replacement portfolio

[Image from Centinel Spine]Centinel Spine announced today that a Texas surgeon completed the first implantation of its Prodisc C VIVO spine implant.

West Chester, Pennsylvania-based Centinel Spine designed the Prodisc C Vivo for cervical total disc replacement (TDR). The company in July received FDA approval for its Prodisc C Vivo, Prodisc C SK and Prodisc C Nova.

Dr. Jason Tinley, orthopedic spine surgeon and founder of the Dallas-Forth Worth Center for Spinal Disorders, performed the first Prodisc C Vivo procedure.

“This patient had severe left-sided neck pain radiating into the forearm and thumb and a left C5/6 disc herniation,” Tinley said in a news release. “Having the intraoperative options of a convex dome with spikes (Prodisc C Vivo) versus a flat endplate component with keel (Prodisc C) gave me the modularity to maximize endplate contact and stability, thus decreasing bone removal, risk of heterotopic ossification, subsidence, or …

Medical Microinstruments launches new NanoWrist instruments for surgical robot

[Image from Medical Microsintruments]Medical Microinstruments announced today that it launched its new supermicro NanoWrist instruments for its Symani surgical robot.

Pisa, Italy-based Medical Microinstruments designed the Nanowrist instruments to address the challenges of microsurgery. Surgeons in Europe recently used the new supermicro needle holder and dilator in clinical procedures with successful outcomes.

According to a news release, surgeons have used the instruments in Zürich (Switzerland), Florence (Italy), and Salzburg (Austria).

In Austria, Dr. Simon Enzinger of the University Hospital Salzburg used them in a partial glossectomy. In the procedure, he raised a lateral arm free flap to replace a large section of a patient’s tongue that required removal due to cancer.

To return blood flow to the transferred tissue, Enzinger used the supermicro NanoWrist instruments to connect the branch of the radial collateral artery to a side brand o…

Penumbra launches RED reperfusion catheters in Europe

[Image from Penumbra]Penumbra (NYSE:PEN) announced today that it received CE mark for its RED reperfusion catheter and began its European launch.

Alameda, California-based Penumbra designed its RED reperfusion catheter for the removal of all clot types in acute ischemic stroke (AIS) patients. Recent data presented by the company demonstrated successful revascularization using the RED system.

Get the full story at our sister site, Medical Tubing & Extrusion.

SeaSpine launches WaveForm TA interbody system

[Image from SeaSpine]SeaSpine (Nasdaq:SPNE) announced that it fully launched the WaveForm TA (TLIF articulating) interbody system.

Carlsbad, California-based SeaSpinedesigned the WaveForm TA interbody system to deliver an interbody to the anterior portion of the disc space. The aim is to optimize sagittal alignment and endplate support.

According to a news release, surgeons can use WaveForm TA to address specific anatomical needs intraoperatively. With a range of footprint and lordotic options, surgeons don’t see adverse impacts to their surgical workflow.

“WaveForm TA is an exciting addition to our interbody portfolio and provides a best-in-class offering in what we estimate is the $175 million U.S. [transforaminal lumbar interbody fusion] market for 3D-printed and solid titanium products,” said Dennis Cirino, SeaSpine SVP of global spinal systems. “This system provides a versatile and reproducible lumbar interbody solution while providing efficiency…

Phase 3 trial data support Glaukos iDose eye drop alternative

Glaukos (NYSE:GKOS) today announced positive outcomes from two Phase 3 pivotal trials for its iDose TR system.

iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP). Glaukos designed it to continuously release therapeutic levels of medication for at least one year. Once all travoprost is released, iDose TR is removed and replaced with an implant, potentially offering an alternative to daily eye drop treatment.

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

Abbott launches Amplatzer Talisman occlusion system in Europe

[Image from Abbott]Abbott (NYSE:ABT) announced today that it launched its Amplatzer Talisman patent foramen ovale (PFO) occlusion system in Europe.

PFO is a hole in the heart that doesn’t close following birth. The company designed the Amplatzer Talisman to treat people with PFO who experienced a stroke and are at risk of having another.

Occlusion with the Talisman PFO is a minimally invasive, catheter-based procedure. It seals off the opening to reduce the risk of another stroke.

Abbott Park, Illinois-based Abbott’s new Talisman PFO occluders come pre-attached to the delivery cable. This design reduces preparation time for doctors and increases ease of use.

Manchester England-based cardiologist Matthew Daniels completed the first European procedure with Talisman PFO.

“Guidelines from industry organizations and clinical trial data continue to reinforce the benefits of PFO closure for people who have had a PFO-associated stro…