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Hologic launches global outreach partnership for Breast Cancer Awareness Month

[Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced a series of activities for October — Breast Cancer Awareness Month.

The slate of activities promotes the importance of breast cancer screenings. It includes a global partnership with Know Your Lemons, a non-profit committed to improving early breast cancer detection. Know Your Lemons provides creative and empowering education on the topic.

Marlborough, Massachusetts-based Hologic kicks things off on Oct. 2. Steve MacMillan, chair, president and CEO, will wring the Nasdaq opening bell that day. Hologic employees, plus tennis legend and two-time breast cancer survivor Martina Navratilova, will join MacMillan.

“For the past 17 years, Hologic has rung the Nasdaq bell at the start of Breast Cancer Awareness Month to draw attention to the impact breast cancer has on our communities and to highlight the enduring need for broader awareness about the critic…

Dentsply Sirona names former NuVasive CEO as board chair

Ex-NuVasive CEO Gregory Lucier will become Dentsply Sirona board chair.

Dentsply Sirona (Nasdaq:XRAY) announced today that it appointed Gregory T. Lucier as chair of its board, effective Jan. 1, 2024.

The appointment of Lucier falls in line with the company’s planned succession process and commitment to periodic board refreshment. Lucier also becomes a member of the board’s corporate governance and nominating committee when his appointment goes into effect.

Following six years as chair, Eric K. Brandt rotates from his role of non-executive chair at the end of the year. He will continue to serve as both a board member and a member of the corporate governance and nominating committee.

Lucier said in a news release that Brandt’s guidance “positioned the company well for future growth.” The newly appointed chair became a director at Dentsply Sirona in 2019. He served as CEO of Corza Health since 2018 and has more than 30 years o…

Fast Five: Abbott data: GLP-1 drugs could boost CGM use, new report claims Philips withheld CPAP problems from the FDA

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 29, 2023.

Fast Five by MassDevice · Abbott says GLP-1s could boost CGM use, new report claims Philips withheld CPAP problems from FDA

Inspira is set to unveil its new line of cardio-pulmonary bypass devices soon. Fast Five hosts Sean Whooley and Danielle Kirsh discuss which devices it is planning to unveil and what they do. Read more here>>

Satio was awarded a $3.5 million contract to develop at-home transdermal drug delivery devices. Hear more about what the transdermal device is and what the contract will allow the company to do. Read more here>>

The FDA has granted an investigational device exemption to EnCompass for its cerebral embolic protection system in TAVR procedures. Whooley explains how the device works and what some of the use data…

PercAssist treats first patient in heart failure support trial

[Image from the PercAssist website]PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study.

The study evaluates PercAssist’s minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients.

Principal investigator Dr. Petr Neuzil completed the first case at the Na Homolce Hospital in Prague, Czech Republic. Also involved were co-investigators Dr. Ivo Skalsky and Dr. Marek Janotka. Neuzil and his team successfully deployed the PercAssist percutaneous synchronized cardiac assist system (PSCA).

The PSCA system features a balloon-based catheter and console. It inflates and deflates in synchrony with the patient’s cardiac rhythm to provide hemodynamic support. Santa Clara, California-based PercAssist said its system was successfully deployed in the study. It provided hemodynamic stability immediately following implantation and throu…

Abbott: Real-world data indicates GLP-1s could be accelerator for FreeStyle Libre

The FreeStyle Libre 3 reader with the sensor and smartphone. [Image courtesy of Abbott]New real-world data from Abbott (NYSE: ABT) + demonstrates a potentially positive impact of GLP-1 drugs on diabetes technology.

GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-like peptide 1, has proven to lead to improved blood sugar control and weight loss.

The drug class continues to grow in popularity and raise questions in medtech around just how large its impact could be.

Positive clinical results for GLP-1s led to recent negative market movement for a few of the biggest names in diabetes technology. Analysts reacted by cutting some forecasts on sales to reflect increased pressure thanks to the GLP-1 updates. Insulet and Embecta noted the drug’s impact in their most recent quarterly earnings. GLP-1s even had an impact on Intuitive Surgi…

Satio wins $3.5M contract to develop at-home transdermal drug delivery device

The SatioRx transdermal drug delivery device. [Image from the company’s website]Satio announced that a National Institutes for Health agency awarded it a $3.5 million Small Business Innovation Research (SBIR) contract.

Awarded by the NIH’s Advanced Research Projects Agency for Health (ARPA-H), the contract helps the company develop SatioRx. This drug delivery device, compact and inexpensive, features disposable microneedle components for precise delivery. It remotely enables the delivery of a precise, metered dose of any liquid drug approved for transdermal delivery.

Under the contract, Boston-based Satio expects to leverage design features from its other patch-based devices. It also plans to utilize feasibility data from its manually operated transdermal delivery devices. Combining these, the company intends to develop a next-generation, remotely controllable device.

Get the full story at our sister site, Drug Delive…

FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures

The F2 device. [Image from the EnCompass Technologies website]EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system.

The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures.

According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — emboli. Emboli can cause injury if they reach the brain. This can occur in procedures like transcatheter aortic valve replacement (TAVR), an ever-growing cardiovascular procedure.

EnCompass’ F2 filter has pores small enough to block most emboli to the brain while preserving blood flow. During the TAVR procedure, 360-degree wall apposition of the filter in the aortic arch prevents migration. The filter, attached to a self-expanding, nitinol stent, is easy to insert, deploy and retrieve.

Earlier this year, …

Inspira to unveil new line of cardio-pulmonary bypass devices

Dagi Ben-Noon, CEO of Inspira Technologies and Dr. Benad Goldwasser, chair of the board of directors. [Image courtesy of Inspira Technologies]Inspira Technologies (Nasdaq:IINN) announced today that it plans to unveil its new Inspira ART line of medical devices.

Ra’anana, Israel-based Inspira plans to debut the devices at the Extracorporeal Life Support Organization (ELSO) Conference in Seattle.

The line of devices includes the ART100 cardio-pulmonary bypass (CPB) device for patients undergoing CPB procedures. Additionally, the company has high hopes for its ART500 device.

Inspira says ART500 represents a significant breakthrough in healthcare with an effective treatment for people facing severe breathing problems. It provides acute respiratory support for patients who may require legacy mechanical ventilation.

The company submitted the ART100 device to the FDA earlier this month. It expects ART100 to receive FDA clearance in the first half of …

Cook Medical wins Vizient’s supplier of the year award

Cook Medical announced on Tuesday that it won the 2023 Vizient Supply Assurance Supplier of the Year Award.

The company received the award at the 2023 Vizient Connections Summit. It said the award demonstrates its transparency and commitment to communication during the supply chain process.

Vizient’s award goes to a company that demonstrates flexibility, innovation and distinction in ensuring the uninterrupted supply of products. These suppliers also have active and comprehensive participation in Vizient’s supply assurance programs or initiatives.

“The last several years have shown massive shifts in supply chain for industries all over the world. This award is an honor to get at any time, but considering the pandemic and many other factors, this award is especially meaningful,” said Ross Harvey, Cook’s VP of global supply chain. “We can’t control everything that goes on in the world, but we can focus on the things we have control over. We can…

Fast Five: Edwards Lifesciences facing antitrust scrutiny in Europe, NIH chooses Boston as ARPA-H Catalyst Hub

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 28, 2023.

Fast Five by MassDevice · Edwards Lifesciences facing antitrust scrutiny in Europe, NIH chooses Boston as ARPA-H Catalyst Hub

QT Medical this week announced it raised $12 million in a Series B funding round. Fast Five hosts Sean Whooley and Danielle Kirsh explain what that technology is and how optimistic executives are feeling after the funding round. Read more here>>

BCIs are in the news again this week. This time, Onward announced the first-in-human implant of a stimulator with BCI technology. Whooley details how the technology works with the BCI and what doctors think after the first implant. Read more here>>

Boston Scientific won an FDA nod for its intravascular ultrasound system. Hear how the system works and how it assists cli…

Philips reportedly withheld CPAP problems from the FDA for years

Philips (NYSE: PHG) + received the first complaints of degraded sound abatement foam in its respiratory devices in 2010, but 11 years passed before it turned into a major recall, according to a ProPublica and Pittsburgh Post-Gazette investigation published today.

According to ProPublica, Philips withheld the vast majority of the warnings about black particles, dirt, dust and other contaminants in devices airway chambers from the FDA even as the reports became more alarming each year.

It wasn’t until 2021 that Philips initiated a recall that now covers 5.5 million CPAPs and other devices. Since April 2021, the FDA received 105,000 reports of problems, including 385 reports of deaths associated with the foam degradation issue. (Here is MassDevice‘s full timeline of the recall.) After he took over in 2022, Philips CEO Roy Jakobs apologized for the recall on behalf of the Dutch medtech giant is deeply sorry ab…

QT Medical raises $12M Series B for ECG device

The PCA 500 12-lead ECG device. [Image courtesy of QT Medical]QT Medical announced that it raised $12 million in a Series B financing to support its cardiac care technology.

Los Angeles-based QT plans for the funding to accelerate its market penetration, global expansion, product development and long-term planning.

The company develops cardiac devices for patients with heart disease. Its flagship Personal Cardiac Assistant (PCA 500), a hospital-grade, resting 12-lead ECG device, has FDA clearance and CE mark. The company designed its wireless, digital, cloud-managed device for convenience with its small size. It weighs 2.3 ounces and measures less than three square inches in size. Smaller than a deck of cards, it fits in a shirt pocket or mailing envelope and utilizes phone and tablet apps.

QT Medical says its proprietary single-use, self-adhesive sensor replaces traditional electrodes and wires. Current uses include commercial flights for inflight medical …