News and Resources from the WTWH Media Life Science Network - Page 208 of 968

May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…

FDA clears smart toilet seat for home heart monitoring from Casana

The Heart Seat smart toilet seat. [Image from Casana’s website]Casana announced today that it received FDA clearance for its Heart Seat — a smart toilet seat that measures certain vital signs.

Heart Seat measures heart rate and oxygen saturation (SpO2). Casana also has partnerships with researchers to conduct validation studies for further clinical measurements. The company plans to file for future indications this year, including systolic and diastolic blood pressure.

Casana aims to initiate the market launch for Heart Seat by the end of 2023.

According to Casana’s website, the Heart Seat passively captures health parameters. It aims to reliably track health trends with no behavior change.

When used, the system unobtrusively gathers health data and analyzes it in context to provide insights into health and trends over time. It then sends data to the designated care team’s dashboard, designed in collaboration with Casana’s par…

Tegra Medical achieves ISO 14001 Environmental Management Certification

NEWS RELEASE: Tegra Medical Achieves ISO 14001 Environmental Management Certification

The medical device manufacturer commits to reducing its environmental impact

Tegra Medical, a leading contract manufacturer of medical devices and a member of SFS, which is headquartered in Heerbrugg Switzerland, today announced it has achieved ISO 14001 certification in all four of its locations in the Americas.

ISO 14001 certification, the world’s most widely recognized standard for Environmental Management Systems, is granted to companies that identify and manage aspects of their business to reduce their environmental impact. Certification is established with a baseline, which is determined after an extensive audit of a company’s procedures.

The audit is followed by a plan for improvement in selected areas. Some of Tegra Medical’s areas upon which to focus improvement include material reuse, waste reduction, composting, and evaluating equipment for a…

Astellas Pharma’s $1.7B Iveric Bio buy aims to bolster its ophthalmology market position

Astellas Pharma, the second largest Japanese pharma firm after Takeda, plans on scooping up the biopharma Iveric Bio for roughly $1.7 billion. Iveric focuses on discovering and developing novel therapies for retinal diseases, for approximately $1.7 billion.

Astellas believes the acquisition of Iveric Bio will strengthen its standing in the ophthalmology market, by adding the latter’s pipeline products to its portfolio. The companies expect the deal to close in the third quarter of 2023.

Zimura, a potential geographic atrophy breakthrough

The centerpiece of the Astellas-Iveric Bio deal is the drug candidate, Zimura (avacincaptad pegol), which is now in phase 3 clinical trials for geographic atrophy. The condition trails age-related macular degeneration (AMD) as a leading cause of irreversible blindness among the elderly. Geographic atrophy is an advanced form of the disease. No therapies are now approved to treat the condition.

Zimura, inhibitor of …

Pulse Biosciences enters $65M private placement for pulsed-field ablation tech

Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a stock purchase agreement to raise approximately $65 million.

Hayward, California-based Pulse Biosciences entered into the agreement with Robert Duggan, the company’s executive chair. Duggan agreed to purchase 10,022,937 shares of the company’s common stock at $6.51 per share. That marks a greater than 1% premium over the last reported sale price of Pulse common stock on April 28, 2023.

Upon the closing of the private placement, all indebtedness owed to Duggan will be canceled as consideration for the shares. That includes the principal balance of $65 million and accrued and unpaid interest of approximately $0.25 million.

Pulse Biosciences develops its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology. It also develops the proprietary CellFX System for the treatment of AFib.

“Upon closing, this transaction eliminates our debt and this ca…

Your Trusted Medical Industry Partners

By John Tranquilli, Materials Manager

Founded in 1971, Apple Rubber has been tackling the world’s toughest sealing challenges, innovating new solutions, and gaining industry expertise for over 50 years. Thanks to their extensive in-house capabilities, their products are able to be fully designed, engineered, and manufactured in-house at their Lancaster, NY facility.

Over the last five decades, Apple Rubber engineers have dedicated themselves to pushing the boundaries of rubber seal design and advancing o-ring and rubber material science. Today, they are a leading designer and manufacturer of seals and sealing devices, serving the needs of countless industries around the world.

At Apple Rubber, the medical industry’s need for precision, dependability, and adherence to the highest of standards is fully understood. When the success or failure of a life-saving medication, vaccine, medical material, or piece of equipment can depend on the effect…

Zimmer Biomet to acquire 3D-printed implant maker Ossis

Zimmer Biomet (NYSE: ZBH) + announced today that it reached a definitive agreement to acquire Ossis, a maker of personalized 3D-printed implants.

Ossis also offers complex hip replacements, including second-time replacements and ones involving bone tumors and trauma.

The company boasts rapid design and production of personalized implants. This aligns with ZB’s commitment to providing personalized experiences, according to a news release.

“Combining Ossis’s more than 16 years of clinical experience and engineering expertise with Zimmer Biomet’s extensive network across Asia Pacific, Europe, the Middle East and Africa demonstrates our commitment to bring transformative med tech advancements to patients in need,” said Sang Yi, Zimmer Biomet Asia Pacific group president.

ZB entered into an agreement with Ossis in July 2021. The agreement made Ossis the company’s Asia Pacifi…

BioAffinity Technologies names Michael Dougherty as CFO

BioAffinity Technologies today announced it appointed Michael Dougherty as chief financial officer, effective immediately.

Dougherty will report directly to President and CEO Maria Zannes. He has more than 20 years of experience in financial management and business strategy. Former CFO Michael Edwards will remain as a consultant to ensure a smooth transition.

“We are delighted to welcome Mike to our executive leadership team. He brings a tremendous skill set developed in senior positions at Amazon and Russell Investments. His expertise in financial management will play an important role in the nationwide commercial rollout of CyPath Lung,” Zannes said in a news release. “His experience in strategy development and M&A will be crucial as we expand the CyPath brand into other indications and pursue therapeutics opportunities. I look forward to his input and leadership as we increase visibility for our Company among investors, analysts and the broader financial…

Building our future: holistic approaches to sustainability and glove manufacturing practices

By Mölnlycke Health Care

Introduction Sustainability extends well beyond the resources and processes we use in manufacturing; it is instilled into every element of our conduct as a business. Mölnlycke is committed to a sustainable future for our planet and is formed around three core pillars: respect for people and the environment, defence of human rights, and the fight against abuse and corruption. In September this year, we open our new manufacturing facility in Kulim, Malaysia. Following the pandemic, patient demand for surgical procedures has risen. The €50 million investment in Kulim supports our ability to manufacture and deliver our industry leading Biogel® surgical gloves to healthcare systems around the world for decades to come. But in a global environment of limited natural resources and complex global supply chains, it has never been more vital to ensure that these three elements of sustainability are reflected in the development and manufacturin…

Medtronic wins FDA nod for next-gen Micra leadless pacemaker

The Micra AV — compared to a dime here — comes in around the size of a multivitamin. [Image from Medtronic]Medtronic (NYSE: MDT) + announced today that it received FDA approval for its Micra AV2 and Micra VR2 leadless pacemakers.

The next-generation, miniaturized, leadless pacemakers offer longer battery life and easier programming compared to previous versions. Medtronic said they also continue to deliver the established benefits of leadless pacing, such as reduced complications compared to traditional pacemakers.

According to a news release, Medtronic Micra AV2 and VR2 bring 40% more battery life compared to previous generations. The devices have a median projected battery life of nearly 16 years (AV2) and 17 years (VR2). Medtronic said this means more than 80% of patients receiving a Micra pacemaker should only need one device for life.

The Micra AV2 also features advanced algorithms that automatically program A…

The Importance of a Soft Start for Critical Applications Requiring High Precision

When a valve is cycled, one can observe the quality of control by measuring and graphing the flow leaving the valve and the input operating the valve, such as electrical current (for coil controlled valves) or steps (for stepper motor controlled valves). This paper will discuss the characteristics of a valve’s performance curve—specifically, where flow begins and how the curve’s trend can indicate certain valve features and their consequences.

When selecting a valve, there are many parameters to look at, but when sensitive equipment is involved and precision is vital to the application, such as in fluid analyses, characteristics of the flow’s lift-off should be considered because initial flow can have a startling impact on the life and operation of the system overall. For example, if a valve allows an abrupt surge of flow, it can cause hydraulic shock (also referred to as water or fluid hammer). This can be seen in Diagram 1 where the circled area s…

Cook Medical treats first patients with venous valve

Cook Medical today announced the first patient treated in a study evaluating its new venous valve for treating chronic venous insufficiency.

Dr. Mauricio Alviar, a principal investigator, treated the first patient in the clinical study. Alviar serves as a vascular surgeon at Clinica de la Costa in Barranquilla, Colombia. Deployment took a few minutes, Alviar noted, and the patient had local anesthesia.

Bloomington, Indiana-based Cook Medical said it’s now testing the valve’s safety and efficacy in a global, multi-site clinical trial. Dr. Paul Gagne of Vascular Care Connecticut serves as global principal investigator. This trial evaluates the safety, efficacy, wound healing, leg pain and disability levels over five years.

“When leg veins function poorly, patients suffer with leg swelling, leg pain, leg ulcers, disability, and possible amputation,” Gagne said. “Therefore, it is important to restore blood flow out of the leg veins, b…