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Tivic Health regains Nasdaq compliance

Tivic Health (Nasdaq:TIVC) announced today that it regained compliance with the minimum bid price requirement on the Nasdaq market.

Earlier this year, San Francisco-based Tivic filed an SEC Form 8-K pertaining to a notice of delisting from the Nasdaq market. The company received notice in January that its closing price fell below $1 for 30 consecutive trading days. It received a six-month grace period to regain compliance. Along with this announcement, the company at that time — late July — reduced its workforce. Tivic appealed that determination and received a scheduled appeal date of tomorrow, Sept. 21.

However, today, the company said it received notice from the Nasdaq market notifying it of its eligibility for continued listing. The company remains in compliance with all applicable listing standards. Consequently, it continues trading on the Nasdaq market under the TIVC ticker, according to a news release.

The bioelectronic medicine maker develops Cl…

European Commission sees potential antitrust activity in medtech

[Image courtesy of Google Satellite]The European Commission has conducted a surprise inspection at an undisclosed medtech company active in the cardiovascular space.

The news release, posted yesterday on the Commission’s website, mentioned concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position.

Other details were not provided, including the identity of the company and the location or country of the inspection.

The news release added: “Unannounced inspections are a preliminary investigative step into suspected anticompetitive practices. The fact that the Commission carries out such inspections does not mean that the company in question is guilty of anti-competitive behavior, nor does it prejudge the outcome of the investigation itself.”

Antitrust regulation enforcement has increased in both the EU and the U.S. in recent years. In 2020, the Commission kicked off a co…

Day Zero Diagnostics completes $16M funding round

Day Zero Diagnostics — which seeks to harness whole-genome sequencing and AI in the fight against antibiotic-resistant infections — announced today that it has successfully wrapped up a $16M financing round.

The latest round raises the Boston-based company’s venture capital funding total to $49M, coupled with over $18M in non-dilutive funding.

“This funding is a strong vote of confidence in Day Zero Diagnostics’ potential to use rapid sequencing and AI to disrupt microbiology lab diagnostics,” Day Zero Diagnostics co-founder and CEO Jong Lee said in a news release.

“DZD is focused on bringing an FDA-cleared diagnostic to market that will deliver the ‘holy grail’ of infectious disease diagnostics – same-day organism identification and antimicrobial susceptibility profiling directly from clinical samples, and our investors share our belief in the game-changing nature of our technology.”

Day Zero Diagno…

Orthofix launches new fixation system, first cases performed

The Galaxy Fixation Gemini system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq: OFIX) + today announced the full U.S. commercial launch and initial successful cases of its Galaxy Fixation Gemini system.

Lewisville, Texas-based Orthofix’s latest Galaxy product offers stable external fixation. It comes in several sterile procedure kit configurations as a quick, off-the-shelf solution. The system treats fractures resulting from trauma in the lower and upper limbs.

Sterile kits eliminate the need for the sterilization of trays, which takes an average of 139 minutes, Orthofix says. In addition to the time consumption, sterilization adds cost to healthcare facilities and can cause operating room delays.

Galaxy Fixation Gemini is the only pin-to-bar system with specific clamps available in a sterile kit configuration, Orthofix says. It gives surgeons more efficient solutions in lower extremity trauma situat…

Stryker launches minimally invasive surgical bunion treatment

The PROstep MIS Lapidus. [Image courtesy of Stryker]Stryker (NYSE: SYK) + announced that it launched the PROstep MIS Lapidus fixation system for bunions.

Kalamazoo, Michigan-based Stryker designed the system to treat bunions using a minimally invasive surgical reduction. It uses the hallux valgus deformity and subsequent fusion of the first metatarsal cuneiform joint.

Traditionally, surgeons performing Lapidus bunion procedures use an open approach. Stryker cites surgeon and patient advantages with minimally invasive techniques, though. PROstep MIS Lapidus offers powerful fixation stability through a minimal incision.

The new technology features MIS joint preparation, triplanar reduction and a three-screw construct that creates a tension band for biomechanical stability.

Stryker highlights benefits including a 2.5% decrease in recurrence compared to open Lapidus procedures. The company saw a 9% reduction in …

Boston Scientific targets M&A, AI to reach ‘next level’

Mike Mahoney, chair and CEO of Boston Scientific. [Photo courtesy of Boston Scientific]Mike Mahoney uses fantasy football to describe Boston Scientific (NYSE: BSX) + — he says that, if creating a medtech team, “it would be the draft you want.”

Speaking at the company’s 2023 Investor Day event, the CEO set the theme as “next level.” He explained his aim to make Boston Scientific a “compelling” and “fantastic place to be 10 years from now.”

The company is making moves — in M&A, digital and more — to invest in that over the long term.

“We’re taking our performance to the next level,” Mahoney said. “We have high aspirations for the company, but we want to do so while always maintaining a great culture — a caring culture for our employees — doing the right things for society while, hopefully, delivering a unique set of financials along the…

Ypsomed concludes autoinjector supply deal with Novo Nordisk

The YpsoMate 1mL autoinjector. [Image from Ypsomed]Ypsomed announced today that it concluded a long-term supply agreement with Novo Nordisk for large quantities of autoinjectors.

Burgdorf, Switzerland-based Ypsomed designed the autoinjectors to administer drugs for the self-treatment of metabolic conditions. It intends to deliver variants of its YpsoMate 1mL autoinjector for various drugs undergoing clinical trials in large quantities. This expands its manufacturing capacities over the coming years.

Novo Nordisk expects to contribute a significant part of the investment for additional production infrastructure. The companies expect availability of a significant capacity of autoinjectors for Novo Nordisk “in the course of 2025.”

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

Fast Five: Boston Scientific makes a $850M acquisition, InBrain Neuroelectronics wins FDA breakthrough nod

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 20, 2023.

Fast Five by MassDevice · Boston Scientific makes a $850M acquisition, InBrain Neuroelectronics wins FDA breakthrough nod

Virtual Incision this week added $30 million in funding for its miniaturized surgical robot. Fast Five hosts Sean Whooley and Danielle Kirsh explain the technology behind the robot and what the company plans to do with the proceeds from the funding round. Read more here>>

Moon Surgical picked up CE mark approval this week for its updated Maestro surgical robot. Find out what the surgical robot does and how optimistic executives are about the future of the company. Read more here>>

The FDA has granted investigational device exemption to Orchestra BioMed for its cardiac neuromod trial in pacemaker patients. Whooley e…

CMR Surgical brings in $165M to support surgical robot

Versius surgical robotics systems [Image courtesy of CMR Surgical]CMR Surgical announced today that it raised a funding round worth $165 million (£133 million) and hit a milestone with its surgical robot.

The Cambridge, UK-based company develops the Versius surgical robotic system. Versius is a small-scale system with collaborative arms and bedside units for direct patient access. It also features freedom of port placement to best suit the needs of each patient. CMR Surgical features on our list of surgical robotics companies you need to know.

According to a news release, the latest round of funding for CMR Surgical was increased due to strong internal demand. All major existing investors, including Ally Bridge Group, Cambridge Innovation Capital, Escala Capital, LGT and its affiliate Lightrock, RPMI Railpen, SoftBank Vision Fund 2 and Tencent and Watrium all led the round.

CMR Surgical earmarked the funds to drive continued product innovation, including ne…

Neuralink opens recruitment for first-in-human BCI trial

Neuralink says its brain-computer interface is fully implantable, cosmetically invisible, and designed to let a person control a computer or mobile device anywhere they go. [Image courtesy of Neuralink]Neuralink, the Elon Musk-backed brain-computer interface (BCI) maker, today announced that it opened recruitment for a clinical trial.

The first-in-human trial — the PRIME study — evaluates the company’s fully implantable, wireless BCI and delivering surgical robot. It assesses the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts.

According to a blog post on Neuralink’s website, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.

Neuralink’s N1 brain implant comes in at about the size of a coin. Remotely rechargeable, the implant goes along with electrode-laced threads that go further into the brain. Neuralink al…

Elutia raises $26M for drug-eluting biomatrix tech

Elutia (Nasdaq:ELUT) announced today that it entered into a securities purchase agreement worth total proceeds of $26.2 million.

The drug-eluting biomatrix company expects the private placement financing to result in initial gross proceeds of approximately $10.5 million. The full exercise of warrants would add $15.8 million to reach a total of $26.2 million.

Silver Spring, Maryland-based Elutia expects the cash raised to support the advancement of its drug-eluting biomatrix products. The company also expects the divestiture of its orthobiologics business to aid in the effort. Elutia develops its drug-eluting products for the pacemaker and defibrillator market, plus breast reconstruction post-mastectomy.

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

InBrain Neuroelectronics wins FDA breakthrough nod for intelligent network modulation system

The graphene-based, high-resolution cortical brain interface. [Image courtesy of InBrain Neuroelectronics]InBrain Neuroelectronics announced today that it received FDA breakthrough device designation for its intelligent network modulation system.

The breakthrough nod covers the graphene-neural platform as an adjunctive therapy for treating Parkinson’s disease.

InBrain’s system harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms. The thin material — stronger than steel, the company says — utilizes a combination of electrical and mechanical properties.

According to InBrain, the neural platform enables ultra-high signal resolution, using machine learning software to decode therapy-specific biomarkers. It delivers highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks.

The semiconductor-derived brain-computer interface (BCI) technology could decode and modulate …