Introduction
This report summarizes the key trends in the domestic and international medical device and MedTech industry during the week of May 25 to June 1, 2026. We will focus on practical insights concerning M&A and technological partnerships, product approvals and regulatory compliance, recalls and quality responses, and financial results.
Key News Highlights
- Olympus announced an agreement to acquire Israel-based BioProtect for $270 million.
- Abbott received CE Mark approval for its Libre Duo series, which can continuously measure both blood glucose and ketones simultaneously.
- Insulet initiated a voluntary Medical Device Correction for certain lots of Omnipod due to a manufacturing issue that could lead to insulin under-delivery.
- DePuy Synthes, a Johnson & Johnson company, announced a definitive agreement to acquire certain rights for the development, manufacturing, and commercialization of Gemtrack RF tracking technology for orthopedic navigation and robotic surgery in the joint reconstruction segment.
- Neurovalens received FDA De Novo authorization for Modius Spero, a non-invasive neuromodulation device for PTSD symptoms.
- Fisher & Paykel Healthcare announced increased revenue and profit for the full fiscal year ending March 2026.
M&A and Technical Alliances
Olympus to Acquire BioProtect for $270 Million (May 26)
Olympus announced on May 26, 2026, that it has entered into an agreement to acquire BioProtect Ltd., an Israeli medical device manufacturer, for $270 million. BioProtect develops a biodegradable balloon spacer that creates space between the prostate and surrounding organs during prostate cancer radiation therapy, thereby reducing radiation exposure to healthy tissues.
Since its commercialization in 2023, the product has been used in over 11,000 procedures worldwide. For Olympus, this acquisition is positioned as an expansion into the cancer treatment adjacent area, building upon its existing urology endoscopy portfolio, including flexible ureteroscopes.
Source: Olympus, "Olympus to Acquire BioProtect to Expand Its Portfolio of Urological Technologies and Address Prostate Cancer," May 26, 2026. https://www.olympus-global.com/news/2026/nr03020.html
DePuy Synthes to Acquire Certain Rights to Gemtrack RF Tracking Technology (May 26)
On May 26, 2026, Johnson & Johnson subsidiary DePuy Synthes announced a definitive agreement to acquire certain rights for the development, manufacturing, and commercialization of Gemtrack, a miniature radiofrequency (RF) tracking technology developed by MinMaxMedical (MMM), within its joint reconstruction portfolio. J&J's announcement clarifies that this is not a full acquisition of the Gemtrack technology itself or an acquisition of MinMaxMedical as a company, but rather an acquisition of technology rights specifically for the joint reconstruction sector.
Gemtrack has the potential to alleviate the limitations of conventional orthopedic navigation and robotic systems, which often rely on infrared cameras or direct line of sight. The technology is intended for use in joint areas, including the shoulder, hip, and knee, and is expected to integrate with DePuy Synthes' VELYS-related portfolio.
Source: Johnson & Johnson, "DePuy Synthes Announces Agreement to Acquire Miniature Radiofrequency Tracking Technology Across its Joint Reconstruction Portfolio," May 26, 2026. https://www.jnj.com/media-center/press-releases/depuy-synthes-announces-agreement-to-acquire-miniature-radiofrequency-tracking-technology-across-its-joint-reconstruction-portfolio
AiM Medical Robotics Collaborates with Siemens Healthineers on MRI-Guided Robotic Neurosurgery (May 26)
On May 26, 2026, AiM Medical Robotics announced a collaboration to implement an interface to integrate Siemens Healthineers' MRI systems with AiM's MRI-compatible robotic platform.
The initiative aims to enable data exchange and coordinated operation between Siemens Healthineers' MAGNETOM MRI scanners and AiM's robotic stereotactic neurosurgery system. This move is relevant to improving the efficiency and precision of MRI-guided procedures such as neurostimulation lead placement, tumor and epilepsy ablation, biopsies, and therapeutic drug delivery.
It should be noted that this announcement pertains to a collaboration and interface implementation, and does not signify product approval or the commencement of commercial sales.
Source: AiM Medical Robotics, "AiM Medical Robotics Announces Collaboration Agreement with Siemens Healthineers to Advance MRI-Guided Robotic Neurosurgery," May 26, 2026. https://www.globenewswire.com/news-release/2026/05/26/3301073/0/en/aim-medical-robotics-announces-collaboration-agreement-with-siemens-healthineers-to-advance-mri-guided-robotic-neurosurgery.html
Product Approval, Regulations, and Quality Compliance
Abbott Receives CE Mark for Libre Duo Series (May 27)
On May 27, 2026, Abbott announced that it has received CE Mark approval for Libre Duo and Libre Duo 10 Day, devices capable of continuously measuring both glucose and ketones simultaneously.
The Libre Duo series aims to continuously monitor elevated ketone levels, which can lead to diabetic ketoacidosis (DKA), in addition to routine glucose management for people with diabetes. Libre Duo is indicated for individuals aged 18 and older for up to 15 days of wear, while Libre Duo 10 Day is indicated for individuals aged 2 and older for up to 10 days of wear.
Source: Abbott, "Abbott secures CE Mark for world's first dual glucose-ketone sensing technology for people with diabetes," May 27, 2026. https://abbott.mediaroom.com/2026-05-27-Abbott-secures-CE-Mark-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes
Insulet Initiates Medical Device Correction for Certain Omnipod Lots (May 26)
On May 26, 2026, Insulet initiated a voluntary Medical Device Correction for certain lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros).
The cause is a manufacturing issue involving small tears in the cannula, which could lead to insufficient insulin delivery into the body and result in underdosing. According to information published by the FDA, unaffected lots can continue to be used, while users of affected lots are instructed to verify and take action. Insulet's FAQ states that 24 serious adverse events have been reported, including hyperglycemia, hospitalization, and diabetic ketoacidosis, with no reported fatalities.
Sources: FDA, "Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets," May 26, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-pods-us-and-affected
Insulet / Omnipod, "Urgent Medical Device Correction." https://www.omnipod.com/mdc-5-26
Neurovalens Obtains FDA De Novo Authorization for Modius Spero for PTSD Treatment (May 26)
On May 26, 2026, Neurovalens announced that it had received FDA De Novo authorization for Modius Spero, a non-invasive neuromodulation device intended to treat PTSD symptoms.
The device is indicated for adults aged 22 and older and is to be used as part of a comprehensive treatment plan under the prescription and supervision of a healthcare professional. According to Neurovalens, in a clinical trial involving 383 participants conducted in the United States, two-thirds of the Modius Spero user group reported clinically meaningful improvements in their PTSD symptoms. The device is expected to be made available to veterans through the U.S. Department of Veterans Affairs.
Source: Neurovalens, "FDA Grants World's First Neuromodulation Device to Treat Symptoms of PTSD," May 26, 2026. https://neurovalens.com/nv_news/fda-grants-worlds-first-neuromodulation-device-to-treat-symptoms-of-ptsd/
50 Years Since the 1976 Medical Device Amendments (May 28)
The FDA has published an article reflecting on the history of U.S. medical device regulation and its current regulatory framework, coinciding with the 50th anniversary of the 1976 Medical Device Amendments.
The 1976 Amendments were a crucial legislative change that established the framework for classifying medical devices into Class I, II, and III based on risk, and laid the foundation for premarket procedures such as PMA and 510(k). Current discussions around medical device regulation, AI medical devices, digital health, and the utilization of real-world data are all extensions of this risk-based regulatory philosophy.
Source: FDA, "Fifty Years of the Medical Device Amendments: Building on a Strong Foundation to Advance Safe, Effective and High-Quality Medical Devices," Content current as of May 28, 2026. https://www.fda.gov/news-events/fda-voices/fifty-years-medical-device-amendments-building-strong-foundation-advance-safe-effective-and-high
Financial Results News
Fisher & Paykel Healthcare Reports Revenue and Profit Growth for FY2026 (May 26)
New Zealand-based Fisher & Paykel Healthcare announced its full-year results for the fiscal year ending March 2026 on May 26, 2026. Revenue increased by 14% year-over-year to NZ$2.31 billion, and net profit after tax rose by 24% to NZ$468.5 million.
Hospital product group sales reached NZ$1.51 billion, an 18% increase year-over-year. Hospital consumables, in particular, showed strong performance and drove the company's growth. The home care product group, including products related to Obstructive Sleep Apnea (OSA), also saw increased revenue.
Source: Fisher & Paykel Healthcare, "Fisher & Paykel Healthcare reports strong revenue and profit growth for the 2026 financial year," May 26, 2026. https://www.fphcare.com/en-ca/corporate/investor/news/fph-reports-strong-revenue-and-profit-growth-2026/
Medical Device News
MannKind Receives FDA Approval for Expanded Indication of Afrezza in Children and Adolescents (May 29)
On May 29, 2026, MannKind announced that it had received FDA approval for its inhaled insulin product, Afrezza, for use in children and adolescents aged 6 and older with type 1 and type 2 diabetes.
While Afrezza is classified as a pharmaceutical product rather than a medical device itself, it is a diabetes treatment that utilizes an inhalation device. As such, it holds relevance as peripheral news within the diabetes digital health and insulin delivery device sector. When included in medical device industry reports, it is appropriate to treat it as "peripheral medical device news."
Source: MannKind, "MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes," May 29, 2026. https://www.globenewswire.com/news-release/2026/05/29/3303734/29517/en/mannkind-announces-fda-approval-of-afrezza-the-first-and-only-inhaled-mealtime-insulin-for-use-in-children-and-adolescents-aged-6-and-older-living-with-diabetes.html
Summary
From May 25th to June 1st, 2026, the medical device industry saw significant M&A and technology partnership activities, including Olympus's acquisition of BioProtect, DePuy Synthes' acquisition of certain rights to Gemtrack technology, and the collaboration between AiM Medical Robotics and Siemens Healthineers.
In terms of regulatory and product developments, key events included Abbott's Libre Duo receiving CE Mark approval, Neurovalens' Modius Spero for PTSD receiving FDA De Novo authorization, and Insulet's Medical Device Correction regarding Omnipod. Insulet's case, in particular, highlights the importance of manufacturing quality, post-market surveillance, and prompt customer response in diabetes management devices.
Financially, Fisher & Paykel Healthcare announced increased revenue and profit, driven by growth in hospital consumables. Additionally, the 50th anniversary of the 1976 Medical Device Amendments provided an opportunity to reflect on the origins of the current risk-based regulatory framework. Investment and product development remain active in the medical device industry, particularly in areas such as single-use and consumable products, chronic disease management, robot-assisted surgery, AI and digital health, and minimally invasive treatments.