MassDevice Archives - Medical Design Sourcing

Benchmarks, Pitfalls, and Proactive Considerations for Exceptional DFM in Precision Metal Components

Design for manufacturability (DFM) is a critical aspect of precision metal components, as it directly impacts the quality, cost, and efficiency of the manufacturing process. We’re discussing four important benchmarks for exceptional DFM in precision metal forming, listing the biggest pitfalls to avoid, followed with proactive tips for DFM success.

Four Important Benchmarks for Exceptional DFM in Precision Metal Forming

Material Selection: Choose the right material for the application. Consider factors such as material properties (e.g., strength, ductility, formability, corrosion resistance), cost, and availability. Selecting the appropriate material can significantly impact the final product’s performance.

Tolerances and Dimensional Control: Define precise dimensional tolerances and specifications. Ensure that the design allows for the required tolerances without compromising the functionality of the part. Achieving tighter tolerances will often require…

How medtech could be affected by a U.S. government shutdown

[Image from Unsplash]The FDA is expected to continue much of its operations if the U.S. government shuts down this weekend, while CMS and the NIH face some government shutdown uncertainties.

The critical deadline for lawmakers in the U.S. to extend federal funding is rapidly approaching, and House Republicans have yet to reach an agreement over passing a bipartisan deal that would prevent a government shutdown. The shutdown would affect Americans’ lives in many ways, including the closure of national parks, museum closures, airport delays, federally-funded infrastructure work and more. However, essential services would continue, and that includes most operations at the FDA.

Presently, the FDA has carryover user fee funding that allows for the agency to continue operations of certain activities, including the regulation of human and animal drugs, biosimilar biological products and medical devices.

Medical device user fees support the review and approva…

SeaStar wins FDA breakthrough nod for selective cytopheretic device

The Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical (Nasdaq:ICU) announced today that the FDA granted breakthrough device designation for its selective cytopheretic device (SCD).

Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting the implantation of a left ventricular assist device (LVAD).

SeaStar’s SCD halts the downward spiral perpetuated by a hyperinflammatory state, SeaStar chief medical officer Dr. Kevin Chung says.

The company said it expects the breakthrough nod to expedite the clinical development and regulatory review of the SCD.

SeaStar submitted a first-in-human study that saw a patient with severe chronic heart failure treated with the SCD. That patient was ineligible for heart tran…

Ypsomed has a new CFO, board member

Samuel Künzli

Ypsomed announced today that it selected Samuel Künzli to take over the company’s chief financial officer (CFO) position.

Niklaus Ramseier elected to hand over the reins to the CFO position after more than 20 years in the post. The transition begins on March 31, 2024, with Ramseier remaining available to the drug delivery device maker for strategic projects. Künzli begins as CFO on April 1, 2024.

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

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 …