AI-Mediated Recalls: Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots

Shots: Product recalls in biopharma and MedTech incur an unanticipated drain on budget, costing the industry between $2.5B to $5B per year on average Honeywell’s TrackWise Recall Management helps biopharma and MedTech companies plan and execute recall processes seamlessly, contributing to improved patient safety and faster response times Shawn Opatka, Vice President & General Manager,…

BySaurabh ChaubeySeptember 1, 2025

NEWS

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

Shots: Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts Trial showed…

ByRidhi RastogiSeptember 1, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:  argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis Read More: argenx PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda…

ByRidhi RastogiAugust 29, 2025

NEWS

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Shots: BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratories ProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…

ByRidhi RastogiAugust 28, 2025

NEWS

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…

ByRidhi RastogiAugust 28, 2025

NEWS

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…

ByRidhi RastogiAugust 27, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 18, 2025 – Aug 22, 2025) 

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, and Biosimilars. Check out our full report below:   HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC Read More: HUTCHMED Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for…

ByRidhi RastogiAugust 22, 2025

NEWS

Artrya Receives the US FDA’s 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque

Shots: The US FDA has granted 510(k) clearance to the Salix Coronary Plaque module for the detection & quantification of coronary artery plaque; Salix is available since Jul 2025 in the US Also, Artrya is partnering with major US hospitals for the upcoming SAPPHIRE study, utilizing Salix Coronary Plaque module, plus it has signed a commercial…

ByRidhi RastogiAugust 22, 2025

NEWS

Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…

ByRidhi RastogiAugust 21, 2025

NEWS

neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Obsessive Compulsive Disorder

Shots: neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat obsessive-compulsive disorder (OCD) The Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways and was previously cleared for major depressive disorder The systems support advanced…

ByRidhi RastogiAugust 21, 2025

AI-Mediated Recalls: Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 2025)

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

PharmaShots Weekly Snapshots (Aug 18, 2025 – Aug 22, 2025)

Artrya Receives the US FDA’s 510(k) Clearance for Salix Coronary Plaque Module to Detect Coronary Artery Plaque

Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Obsessive Compulsive Disorder

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